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The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
IB-STIM
01-1020
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for image
guided surgical procedures. The RegistrationPointert Cranial is designed to be used with the Fiagon Navigation
system. The instrument is an accessory to the Fiagon Navigation system produced by fiagon GmbH.
The instrument is accessories to the Fiagon Navigation system.
The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be
appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified
relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution
- EFIAE012003CUS1 ()
- EFIAE012003CUS0 ()
- Multi-purpose stereotactic surgery system
The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided
surgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which is
designed to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigation
system produced by Fiagon GmbH.
The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomical
structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using
electromagnetic navigation.
The Fiagon Navigation – Extended Instrument Set ENT is indicated for any medical condition in which the use of
stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT
surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution
- EFIAE0120031 ()
- EFIAE0120030 ()
- Multi-purpose stereotactic surgery system
METAL-BITE ® Blue is an universal and scannable registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® Blue is extremely fast, hard and thixotropic. It is easy to trim, very suitable for cutting and contouring. The material has no taste at all, is radiopaque and offers an excellent dimension stability.
Further on METAL-BITE ® Blue is predestined for static hicp and antagonist registrations, dynamic registrations according to FGP methods and classical facebow registrations. The registrations can then be scanned.
METAL-BITE ® Blue was introduced with and for SIRONA CEREC systems (especially CEREC AC Bluecam) in early 2009. The Dental Advisor compared in its "Editors’ Note" METAL-BITE ® Blue with the classical METAL-BITE. METAL-BITE ® Blue is marketed worldwide. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas and can be dispensed with a commercial dispenser.
R-Dental Dentalerzeugnisse GmbH
MBK0475
In Commercial Distribution
- ERDEMBK04751 ()
- CARTRIDGES2 ()
MBK0475
- Silicone dental impression material
isolate Non Latex Dental Dam in Medium Blue. Each sheet measures 5x5 and is manufactured from Polyisoprene.
Endo/Tech
i5NLMB
In Commercial Distribution
- D052I5NLMB1 ()
i5NLMB
- Rubber dam, non-latex
APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution
- B628APV2C0 ()
APV2C
- Kinesiology ambulatory recorder
Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE).
INCELLDX, INC.
U31100
In Commercial Distribution
- B766U311000 ()
- Total Volume: 100 Microliter
U31100
- Cytokeratin IVD, antibody
The Mayo-Hegar Needle Holder is a surgical instrument designed for holding and driving needles during suturing procedures.
CONCISE ENTERPRISES
190634214
In Commercial Distribution
- G2021906342140 ()
19-06342-14
- Suturing needle holder, single-use
Wiles Hydrodissection Cannula 25ga, J-Shaped Cannula is gently Angled 135 degrees to facilitate Hydrodissection, 21mm Overall Length
Crestpoint Management Limited
CA1305
In Commercial Distribution
- G412CA13050 ()
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
POLYTECHNIC RESOURCES INC
S100758NKNW
In Commercial Distribution
- S100758NKNW0 ()
- S100758NKNW1 ()
- Outer Diameter: 28.4 Millimeter
- Pulmonary function testing kit