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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Construct® Ankle Fusion Plate System - 10381780118145

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6545LT
Not in Commercial Distribution

  • M269PSS6545LT1 ()
  • 10381780118145 ()

  • 1.932 in L x .256 in dia
PSS6545LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118138

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6545CT
Not in Commercial Distribution

  • M269PSS6545CT1 ()
  • 10381780118138 ()

  • 1.913 in L x .256 in dia
PSS6545CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118121

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6540LT
Not in Commercial Distribution

  • M269PSS6540LT1 ()
  • 10381780118121 ()

  • 1.735 in L x .256 in dia
PSS6540LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118114

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6540CT
Not in Commercial Distribution

  • M269PSS6540CT1 ()
  • 10381780118114 ()

  • 1.716 in L x .256 in dia
PSS6540CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118107

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6538LT
Not in Commercial Distribution

  • M269PSS6538LT1 ()
  • 10381780118107 ()

  • 1.656 in L x .256 in dia
PSS6538LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118091

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6538CT
Not in Commercial Distribution

  • M269PSS6538CT1 ()
  • 10381780118091 ()

  • 1.637 in L x .256 in dia
PSS6538CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118084

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6536LT
Not in Commercial Distribution

  • M269PSS6536LT1 ()
  • 10381780118084 ()

  • 1.577 in L x .256 in dia
PSS6536LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118077

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6536CT
Not in Commercial Distribution

  • M269PSS6536CT1 ()
  • 10381780118077 ()

  • 1.558 in L x .256 in dia
PSS6536CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118060

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6534LT
Not in Commercial Distribution

  • M269PSS6534LT1 ()
  • 10381780118060 ()

  • 1.499 in L x .256 in dia
PSS6534LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118053

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6534CT
Not in Commercial Distribution

  • M269PSS6534CT1 ()
  • 10381780118053 ()

  • 1.480 in L x .256 in dia
PSS6534CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118046

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6532LT
Not in Commercial Distribution

  • M269PSS6532LT1 ()
  • 10381780118046 ()

  • 1.420 in L x .256 in dia
PSS6532LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118039

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6532CT
Not in Commercial Distribution

  • M269PSS6532CT1 ()
  • 10381780118039 ()

  • 1.401 in L x .256 in dia
PSS6532CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118022

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6530LT
Not in Commercial Distribution

  • M269PSS6530LT1 ()
  • 10381780118022 ()

  • 1.341 in L x .256 in dia
PSS6530LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780118015

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6530CT
Not in Commercial Distribution

  • M269PSS6530CT1 ()
  • 10381780118015 ()

  • 1.322 in L x .256 in dia
PSS6530CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780117995

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6526LT
Not in Commercial Distribution

  • M269PSS6526LT1 ()
  • 10381780117995 ()

  • 1.184 in L x .256 in dia
PSS6526LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780117971

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6522LT
Not in Commercial Distribution

  • M269PSS6522LT1 ()
  • 10381780117971 ()

  • 1.026 in L x .256 in dia
PSS6522LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780117964

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6520LT
Not in Commercial Distribution

  • M269PSS6520LT1 ()
  • 10381780117964 ()

  • .947 in L x .256 in dia
PSS6520LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780117933

Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4575LT
Not in Commercial Distribution

  • M269PSS4575LT1 ()
  • 10381780117933 ()

  • 3.093 in L x .177 in dia
PSS4575LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Construct® Ankle Fusion Plate System - 10381780117889

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4565CT
Not in Commercial Distribution

  • M269PSS4565CT1 ()
  • 10381780117889 ()

  • 2.700 in L x .177 in dia
PSS4565CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

UNI-CP™ - 10381780042723

The instrument tray base is part of the container which product number is 339950ND and that is used for transport and sterilization of instruments. It is also part of the container which product number is 339900ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
339920ND
Not in Commercial Distribution

  • M248339920ND1 ()
  • 10381780042723 ()


  • Device sterilization/disinfection container, reusable

LapBox Power - 07290118830023

The LapBox Power Contained Tissue Extraction System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be power morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
ARK SURGICAL LTD
ARK-P01
In Commercial Distribution

  • 07290118830023 ()
  • 07290118830030 ()


  • Tissue extraction bag

LapBox Tissue Containment Removal System - 07290118830009

The LapBox Tissue Containment Removal System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be manually morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
ARK SURGICAL LTD
ARK-M01
In Commercial Distribution

  • 07290118830016 ()
  • 07290118830009 ()


  • Tissue extraction bag

Hu-Friedy - 10889950113100

222 Lower Molars, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF222IS
In Commercial Distribution

  • 10889950113100 ()


  • Tooth extraction forceps

Hu-Friedy - 10889950113094

151 Lower Universal, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF151IS
In Commercial Distribution

  • 10889950113094 ()


  • Tooth extraction forceps

Hu-Friedy - 10889950113087

150 Upper Universal, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF150IS
In Commercial Distribution

  • 10889950113087 ()


  • Tooth extraction forceps

Hu-Friedy - 10889950113070

1 Upper Anterior, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF1IS
In Commercial Distribution

  • 10889950113070 ()


  • Tooth extraction forceps

Hu-Friedy - 10889950113056

53L Upper Molar, Left, IS Forceps
HU-FRIEDY MFG. CO., LLC
F53LIS
In Commercial Distribution

  • 10889950113056 ()


  • Tooth extraction forceps

Hu-Friedy - 10889950113049

53R Upper Molar, Right, IS Forceps
HU-FRIEDY MFG. CO., LLC
F53RIS
In Commercial Distribution

  • 10889950113049 ()


  • Tooth extraction forceps

SUDOSCAN - 03770025753065

SUDOTEST is Hand Smart Electrodes Dock
IMPETO MEDICAL
SUDOTEST
In Commercial Distribution

  • 03770025753065 ()
ADSPHD

  • Skin electrical conductance meter

Lansinoh 8oz Bottle with NaturalWave Nipple - 00044677710558

It is used for baby feeding.
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
P71055-00
In Commercial Distribution

  • 10044677710555 ()
  • 00044677710558 ()
  • 40044677710556 ()


  • Breast pump, electric

Lansinoh 5oz Bottle with Natural WaveNipple - 00044677710534

It is used for baby feeding.
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
P71053-00
In Commercial Distribution

  • 10044677710531 ()
  • 40044677710532 ()
  • 00044677710534 ()


  • Breast pump, electric

iProvèn - 08719699636651

BBB-112 Blue is a heating pad
Sevenground Trading B.V.
BBB-112 Blue
In Commercial Distribution

  • 08719699636651 ()


  • Insect bite/sting hyperthermia device

iProvèn - 08719699636644

BBB-112 Grey is a heating pad
Sevenground Trading B.V.
BBB-112 Grey
In Commercial Distribution

  • 08719699636644 ()


  • Insect bite/sting hyperthermia device

Keenhealth - 08719699632530

K-NW-237 is a nasal wash bottle
Sevenground Trading B.V.
K-NW-237
In Commercial Distribution

  • 08719699632530 ()


  • Nasal irrigation applicator

Keenhealth - 08719699632394

K-MB-716 is an Adjustable maternity Belt
Sevenground Trading B.V.
K-MB-716
In Commercial Distribution

  • 08719699632394 ()


  • Abdominal binder, reusable

LEVL - G338KIT0041

This is the LEVL Starter package.
Medamonitor, LLC
1
In Commercial Distribution

  • G338KIT0041 ()
KIT004

  • Breath ketone IVD, kit, rapid colorimetric, clinical

Halyard - 10680651337372

HALYARD* INTEGUSEAL* Microbial Sealant IS 200
Avanos Medical, Inc.
33737
In Commercial Distribution

  • 20680651337379 ()
  • 10680651337372 ()
  • 30680651337376 ()
33737-01

  • Surgical skin microbial sealant

Halyard - 10680651337365

HALYARD* INTEGUSEAL* Microbial Sealant IS 100
Avanos Medical, Inc.
33736
In Commercial Distribution

  • 30680651337369 ()
  • 20680651337362 ()
  • 10680651337365 ()
33736-01

  • Surgical skin microbial sealant

QUCARE®Self Total Cholesterol - 08806141302896

The device is included 2 pouch
DFI CO.,LTD
6407
Not in Commercial Distribution

  • 08806141302896 ()


  • Total cholesterol lipid IVD, reagent

AYA Optical - 00628120774740

Wakan-Matte Black - Sun is Life JY
Claudia Alan Inc
AYO0424BLK
In Commercial Distribution

  • 00628120774740 ()


  • Spectacle frame
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