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PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile
and is provided in sheet form in a variety of sizes to be trimmed by the
surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-114
Not in Commercial Distribution
- 10381780113683 ()
- 4 x 4 x (0.20 - 1.04) cm x cm x mm
6495-9-114
- Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile
and is provided in sheet form in a variety of sizes to be trimmed by the
surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-108
Not in Commercial Distribution
- 10381780113676 ()
- 8 x 8 x (0.20 - 1.04) cm x cm x mm
6495-9-108
- Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile
and is provided in sheet form in a variety of sizes to be trimmed by the
surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-106
Not in Commercial Distribution
- 10381780113669 ()
- 6 x 6 x (0.20 - 1.04) cm x cm x mm
6495-9-106
- Animal-derived wound matrix dressing
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile
and is provided in sheet form in a variety of sizes to be trimmed by the
surgeon to meet the individual patient's needs.
TEI BIOSCIENCES INC.
6495-9-104
Not in Commercial Distribution
- 10381780113652 ()
- 4 x 4 x (0.20 - 1.04) cm x cm x mm
6495-9-104
- Animal-derived wound matrix dressing
ClearVue™ Mountant XYL is a xylene-based rapid drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage. ClearVue Mountant is approved specifically for use with the ClearVue coverslipper.
RICHARD-ALLAN SCIENTIFIC COMPANY
ClearVue™ XYL Mountant
In Commercial Distribution
- 00673693275194 ()
4212
- Microscopy mounting medium IVD
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1225N
In Commercial Distribution
- 00085412530628 ()
PC1225NBIO
- Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016N
In Commercial Distribution
- 00085412530604 ()
PC1016NBIO
- Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814N
In Commercial Distribution
- 00085412530581 ()
PC0814NBIO
- Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608N
In Commercial Distribution
- 00085412530567 ()
PC0608NBIO
- Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404N
In Commercial Distribution
- 00085412530529 ()
PC0404NBIO
- Cardiovascular patch, animal-derived
The medilog®AR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attachingelectrodes, etc.) is performed by the technician or doctor.
Schiller AG
1A.306010
In Commercial Distribution
- 07613365003765 ()
- 07613365003697 ()
1A.306010
- Electrocardiographic ambulatory recorder
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080S
Not in Commercial Distribution
- 00814321020186 ()
- Electromagnetic blood flowmeter
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090S
Not in Commercial Distribution
- 00814321020162 ()
- Electromagnetic blood flowmeter
BresoSensor is a component of BresoDX1. During a test, BresoSensor is placed on the suprasternal notch of a patient and collects the tracheal sound and tracheo-sternal motion through a microphone and three-dimensional accelerometer. The BresoSensor is powered by an internal Lithium-ion rechargeable battery. It is only sold in USA.
BresoTec Inc
BTSM1US-URU
In Commercial Distribution
- 00990008600022 ()
- Home-use sleep apnoea recording system
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-HT
In Commercial Distribution
- M973BL06161 ()
BH201M
- Vascular microcatheter
- Bronchial balloon catheter
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-34
Not in Commercial Distribution
- M973BH201M1 ()
BH201M
- Vascular microcatheter
- Bronchial balloon catheter
A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. The Oxygen Holder is an accessory that attaches to a medical device to hold an oxygen tank.
Pride Mobility Products Corp
Oxygen Holder
In Commercial Distribution
- 00606509800006 ()
N/A
- Wheelchair medical gas supply holder
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080N
Not in Commercial Distribution
- 10814321020176 ()
- 00814321020179 ()
- Electromagnetic blood flowmeter
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090N
Not in Commercial Distribution
- 10814321020152 ()
- 00814321020155 ()
- Electromagnetic blood flowmeter
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.
The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter.
The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5050
In Commercial Distribution
- EAMIICT50500 ()
- Basic power supply, reusable
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.
The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter.
The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5010
In Commercial Distribution
- EAMIICT50100 ()
- Basic power supply, reusable
6' Electrode Lead Wire Set for use with the Uroval BRS System.
UROVAL, INC.
BR5338 UDI Not Req as is component
In Commercial Distribution
- 00852523007024 ()
- Length: 6 Feet
- Analytical non-scalp cutaneous lead
CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45225-75100
In Commercial Distribution
- B467CSP4522575100 ()
- B467CSP452257510016 ()
CSP3
- Haemodialysis concentrate
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
165
In Commercial Distribution
- 00850011324165 ()
- Height: 11 Millimeter
- Width: 13 Millimeter
VAL-CA-13-11
- Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
158
In Commercial Distribution
- 00850011324158 ()
- Height: 9 Millimeter
- Width: 13 Millimeter
VAL-CA-13-09
- Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
134
In Commercial Distribution
- 00850011324134 ()
- Height: 13 Millimeter
- Width: 13 Millimeter
VAL-CA-13-13
- Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
110
In Commercial Distribution
- 00850011324110 ()
- Height: 9 Millimeter
- Width: 10 Millimeter
VAL-CA-10-09
- Metallic spinal fusion cage, non-sterile
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
004
In Commercial Distribution
- 00850011324004 ()
- Width: 13 Millimeter
- Height: 8 Millimeter
VAL-CA-13-08
- Metallic spinal fusion cage, non-sterile
The TETH-XTN-MM-8 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-8 Meter
In Commercial Distribution
- 00850011306109 ()
31-0613-0005
- Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-5 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-5 Meter
In Commercial Distribution
- 00850011306093 ()
31-0613-0004
- Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-2 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-2 Meter
In Commercial Distribution
- 00850011306086 ()
31-0613-0003
- Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-1 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-1 Meter
In Commercial Distribution
- 00850011306079 ()
31-0613-0002
- Electrical-only medical device connection cable, reusable
is a sterile sponge for wound dressing, prepping, and scrubbing.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution
- 10850014433243 ()
- 00850014433246 ()
- 20850014433240 ()
- Height: 2 Inch
- Length: 2 Inch
DU1202
- Non-woven gauze pad, non-sterile
The EsoSure Esophageal Retractor is intended to move the esophagus.
NORTH EAST SCIENTIFIC INC
100001
100001
- Intraluminal oesophageal retractor
ClearCheck is intended for quality assessment of radiotherapy treatment plans.
Radformation, Inc
2.0
In Commercial Distribution
- 00860001672701 ()
- Radiation therapy software
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22S
In Commercial Distribution
- 00856324008730 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B15
In Commercial Distribution
- 00856324008723 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22
In Commercial Distribution
- 00856324008693 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22
In Commercial Distribution
- 00856324008099 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
oneNEST S 80''x 35'' is a non-powered foam surface
Umano Medical Inc
303-803508HS4FB-BIL
In Commercial Distribution
- 00670482000708 ()
- 10670482000705 ()
303-803508HS4FB-BIL
- Foam bed mattress
oneNEST S 84" x 35'' is a non-powered foam surface
Umano Medical Inc
303-843508HS4FB-BIL
In Commercial Distribution
- 00670482000692 ()
- 10670482000699 ()
303-843508HS4FB-BIL
- Foam bed mattress
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64523-TRI
In Commercial Distribution
- 10670482000583 ()
- 00670482000586 ()
FA64523-TRI
- Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64521-TRI
In Commercial Distribution
- 10670482000576 ()
- 00670482000579 ()
FA64521-TRI
- Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64507-TRI
In Commercial Distribution
- 10670482000569 ()
- 00670482000562 ()
FA64507-TRI
- Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64508-TRI
In Commercial Distribution
- 10670482000545 ()
- 00670482000548 ()
FA64508-TRI
- Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64506-TRI
In Commercial Distribution
- 10670482000538 ()
- 00670482000531 ()
FA64506-TRI
- Freestanding/bed-attached intravenous pole
This is the Metabolic Solutions Kit version of the kit.
Otsuka America Pharmaceutical Inc
01M
In Commercial Distribution
- 00857335005039 ()
- 10857335005043 ()
- Helicobacter pylori urease IVD, kit, chromogenic
LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
In Commercial Distribution
- 05708265011896 ()
- 05708265011889 ()
OP-LAS16-3
- Mechanical-cutting endoscopic polypectomy snare
LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
Not in Commercial Distribution
- 05708265011537 ()
- 05708265011544 ()
OP-LAS16-3
- Mechanical-cutting endoscopic polypectomy snare
Paste used to polish teeth after dental restoration is complete
Bioclear Matrix Systems
Mint
In Commercial Distribution
- D9497001111 ()
- Dentifrice