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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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NA - 04042409174346

Screwdriver cannulated CS 6.5/7.5, hex. ø5.0, Hudson
aap Implantate AG
IS 2405-32
In Commercial Distribution

  • 04042409174346 ()


  • Surgical screwdriver, reusable

NA - 04042409097256

Screwdriver cannulated CS 5.8, hexagonal, ø3.5
aap Implantate AG
IS 2401-22
In Commercial Distribution

  • 04042409097256 ()


  • Surgical screwdriver, reusable

Millennium - 00190776401795

Lucae Mallet 8", 8oz [227g], head stainless steel concave/flat diameter 25mm, stainless steel handle
Avalign Technologies, Inc.
1-250408CC
In Commercial Distribution

  • 00190776401795 ()


  • Surgical mallet

Millennium - 00190776400064

Mallet Combo, nylon & stainless steel heads, stainless steel shaft & handle
Avalign Technologies, Inc.
1-851MSSS
In Commercial Distribution

  • 00190776400064 ()


  • Surgical mallet

Millennium - 00190776399962

Soft Impact Mallet, 3lbs, 50mm head, SS Shaft 8" OL
Avalign Technologies, Inc.
1-7837-8
In Commercial Distribution

  • 00190776399962 ()


  • Surgical mallet

GBR System - 08800041000258

No Description
Surgident Co.,Ltd.
SDP-T44-044
In Commercial Distribution

  • 08800041000258 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

GBR System - 08800041000241

No Description
Surgident Co.,Ltd.
SDP-T36-022
In Commercial Distribution

  • 08800041000241 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

GBR System - 08800041000234

No Description
Surgident Co.,Ltd.
SDP-T22-015
In Commercial Distribution

  • 08800041000234 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

GBR System - 08800041000227

No Description
Surgident Co.,Ltd.
SDP-S44-044
In Commercial Distribution

  • 08800041000227 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

GBR System - 08800041000210

No Description
Surgident Co.,Ltd.
SDP-S36-022
In Commercial Distribution

  • 08800041000210 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

GBR System - 08800041000203

No Description
Surgident Co.,Ltd.
SDP-S22-015
In Commercial Distribution

  • 08800041000203 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

ZipE® Knotless Tissue Repair and Attachment Devices - 10858816006030

ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
A6-6545-S
In Commercial Distribution

  • 10858816006030 ()


  • Tendon/ligament bone anchor, non-bioabsorbable

ZipE® Knotless Tissue Repair and Attachment Devices - 10858816006023

ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
A6-6550-S
In Commercial Distribution

  • 10858816006023 ()


  • Tendon/ligament bone anchor, non-bioabsorbable

ZipE® Knotless Tissue Repair and Attachment Devices - 10858816006016

ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
RA6-6565-S
In Commercial Distribution

  • 10858816006016 ()


  • Tendon/ligament bone anchor, bioabsorbable

ZipE® Knotless Tissue Repair and Attachment Devices - 10858816006009

ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
RA6-6550-S
In Commercial Distribution

  • 10858816006009 ()


  • Tendon/ligament bone anchor, bioabsorbable

Repair Torque Driver for Torque Wrench - 08800040627814

No Description
Osstem Implant Co., Ltd.
TRHD12SR
In Commercial Distribution

  • 08800040627814 ()


  • Surgical screwdriver, reusable

Repair Torque Driver for Torque Wrench - 08800040627807

No Description
Osstem Implant Co., Ltd.
TRHD12LR
In Commercial Distribution

  • 08800040627807 ()


  • Surgical screwdriver, reusable

TS Rigid Outer Driver - 08800040627388

No Description
Osstem Implant Co., Ltd.
ORD45L
In Commercial Distribution

  • 08800040627388 ()


  • Surgical screwdriver, reusable

EXP Mount Driver - 08800040626923

No Description
Osstem Implant Co., Ltd.
AESMDS
In Commercial Distribution

  • 08800040626923 ()


  • Surgical screwdriver, reusable

Abutment removal tip - 08800040624004

No Description
Osstem Implant Co., Ltd.
OARTR
In Commercial Distribution

  • 08800040624004 ()


  • Surgical screwdriver, reusable

Torque Driver for Denture - 08800040623861

No Description
Osstem Implant Co., Ltd.
MSDTS
In Commercial Distribution

  • 08800040623861 ()


  • Surgical screwdriver, reusable

Torque Driver for Denture - 08800040623854

No Description
Osstem Implant Co., Ltd.
MSDTL
In Commercial Distribution

  • 08800040623854 ()


  • Surgical screwdriver, reusable

NoMount Torque Driver - 08800040623045

No Description
Osstem Implant Co., Ltd.
GSNMT35S
In Commercial Distribution

  • 08800040623045 ()


  • Surgical screwdriver, reusable

NoMount Torque Driver - 08800040623038

No Description
Osstem Implant Co., Ltd.
GSNMT35E
In Commercial Distribution

  • 08800040623038 ()


  • Surgical screwdriver, reusable

NoMount Torque Driver - 08800040623021

No Description
Osstem Implant Co., Ltd.
GSNMT32E
In Commercial Distribution

  • 08800040623021 ()


  • Surgical screwdriver, reusable

NoMount Driver - 08800040623014

No Description
Osstem Implant Co., Ltd.
GSNMD35S
In Commercial Distribution

  • 08800040623014 ()


  • Surgical screwdriver, reusable

NoMount Driver - 08800040623007

No Description
Osstem Implant Co., Ltd.
GSNMD32S
In Commercial Distribution

  • 08800040623007 ()


  • Surgical screwdriver, reusable

Excellent Solid Abutment Driver - 08800040622444

No Description
Osstem Implant Co., Ltd.
ESDSS
In Commercial Distribution

  • 08800040622444 ()


  • Surgical screwdriver, reusable

NoMount Torque Driver - 08800040621072

No Description
Osstem Implant Co., Ltd.
GSNMT32S
In Commercial Distribution

  • 08800040621072 ()


  • Surgical screwdriver, reusable

Fixture Driver - 08800040620389

No Description
Osstem Implant Co., Ltd.
USWFDL
In Commercial Distribution

  • 08800040620389 ()


  • Surgical screwdriver, reusable
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