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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 - 10885862056511

FEMORAL NOTCH GUIDE, CC, SIZE 1
Exactech, Inc.
209-53-01
In Commercial Distribution

  • 10885862056511 ()

  • SIZE 1
209-53-01

  • Osteotomy guide, reusable

NA - 10885862056498

TRIAL, CC SPINE, SIZE 1 DELTA
Exactech, Inc.
209-52-10
In Commercial Distribution

  • 10885862056498 ()

  • SIZE 1
209-52-10

  • Knee tibia prosthesis trial, reusable

NA - 10885862056382

FEMORAL FINISHING GUIDE, CC, SIZE 5
Exactech, Inc.
209-51-05
In Commercial Distribution

  • 10885862056382 ()

  • SIZE 5
209-51-05

  • Osteotomy guide, reusable

NA - 10885862056375

FEMORAL FINISHING GUIDE, CC, SIZE 4
Exactech, Inc.
209-51-04
In Commercial Distribution

  • 10885862056375 ()

  • SIZE 4
209-51-04

  • Osteotomy guide, reusable

NA - 10885862056368

FEMORAL FINISHING GUIDE, CC, SIZE 3
Exactech, Inc.
209-51-03
In Commercial Distribution

  • 10885862056368 ()

  • SIZE 3
209-51-03

  • Osteotomy guide, reusable

NA - 10885862056351

FEMORAL FINISHING GUIDE, CC, SIZE 2
Exactech, Inc.
209-51-02
In Commercial Distribution

  • 10885862056351 ()

  • SIZE 2
209-51-02

  • Osteotomy guide, reusable

NA - 10885862056344

FEMORAL FINISHING GUIDE, CC, SIZE 1
Exactech, Inc.
209-51-01
In Commercial Distribution

  • 10885862056344 ()

  • SIZE 1
209-51-01

  • Osteotomy guide, reusable

NA - 10885862056337

FEMORAL LATERAL TEMPLATE, CC, SIZE 5
Exactech, Inc.
209-47-05
In Commercial Distribution

  • 10885862056337 ()

  • SIZE 5
209-47-05

  • Surgical implant template, reusable

NA - 10885862056320

FEMORAL LATERAL TEMPLATE, CC, SIZE 4
Exactech, Inc.
209-47-04
In Commercial Distribution

  • 10885862056320 ()

  • SIZE 4
209-47-04

  • Surgical implant template, reusable

NA - 10885862056313

FEMORAL LATERAL TEMPLATE, CC, SIZE 3
Exactech, Inc.
209-47-03
In Commercial Distribution

  • 10885862056313 ()

  • SIZE 3
209-47-03

  • Surgical implant template, reusable

NA - 10885862056306

FEMORAL LATERAL TEMPLATE, CC, SIZE 2
Exactech, Inc.
209-47-02
In Commercial Distribution

  • 10885862056306 ()

  • SIZE 2
209-47-02

  • Surgical implant template, reusable

NA - 10885862056290

FEMORAL LATERAL TEMPLATE, CC, SIZE 1
Exactech, Inc.
209-47-01
In Commercial Distribution

  • 10885862056290 ()

  • SIZE 1
209-47-01

  • Surgical implant template, reusable

NA - 10885862056283

FEMORAL FINISHING GUIDE BUSHING, CC, 7°
Exactech, Inc.
209-46-07
In Commercial Distribution

  • 10885862056283 ()

  • Angle: 7 degree
209-46-07

  • Osteotomy guide, reusable

NA - 10885862056276

FEMORAL FINISHING GUIDE BUSHING, CC, 6°
Exactech, Inc.
209-46-06
In Commercial Distribution

  • 10885862056276 ()

  • Angle: 6 degree
209-46-06

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 10885862056269

FEMORAL FINISHING GUIDE BUSHING, CC, 5°
Exactech, Inc.
209-46-05
In Commercial Distribution

  • 10885862056269 ()

  • Angle: 5 degree
209-46-05

  • Osteotomy guide, reusable

NA - 10885862056252

FEMORAL FINISHING GUIDE BUSHING, CC, 2°
Exactech, Inc.
209-46-02
In Commercial Distribution

  • 10885862056252 ()

  • Angle: 2 degree
209-46-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 10885862056245

FEMORAL VALGUS ANGLE ADAPTOR, CC, 7°
Exactech, Inc.
209-45-07
In Commercial Distribution

  • 10885862056245 ()

  • Angle: 7 degree
209-45-07

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 10885862056238

FEMORAL VALGUS ANGLE ADAPTOR, CC, 5°
Exactech, Inc.
209-45-05
In Commercial Distribution

  • 10885862056238 ()

  • Angle: 5 degree
209-45-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 10885862054654

TRIAL, CC FEMORAL, OPTIMIZED, SIZE 5
Exactech, Inc.
209-01-15
In Commercial Distribution

  • 10885862054654 ()

  • SIZE 5
209-01-15

  • Knee femur prosthesis trial, reusable

NA - 10885862054647

TRIAL, CC FEMORAL, OPTIMIZED, SIZE 4
Exactech, Inc.
209-01-14
In Commercial Distribution

  • 10885862054647 ()

  • SIZE 4
209-01-14

  • Knee femur prosthesis trial, reusable

NA - 10885862054630

TRIAL, CC FEMORAL, OPTIMIZED, SIZE 3
Exactech, Inc.
209-01-13
In Commercial Distribution

  • 10885862054630 ()

  • SIZE 3
209-01-13

  • Knee femur prosthesis trial, reusable

NA - 10885862054623

TRIAL, CC FEMORAL, OPTIMIZED, SIZE 2
Exactech, Inc.
209-01-12
In Commercial Distribution

  • 10885862054623 ()

  • SIZE 2
209-01-12

  • Knee femur prosthesis trial, reusable

NA - 10885862054616

TRIAL, CC FEMORAL, OPTIMIZED, SIZE 1
Exactech, Inc.
209-01-11
In Commercial Distribution

  • 10885862054616 ()

  • SIZE 1
209-01-11

  • Knee femur prosthesis trial, reusable

General Instruments - 00840180539545

Slim Sigma TLIF CC Blade 90mm
ALPHATEC SPINE, INC.
CI-11840-90
In Commercial Distribution

  • 00840180539545 ()


  • Surgical retraction system, reusable

General Instruments - 00840180539538

Slim Sigma TLIF CC Blade 70mm
ALPHATEC SPINE, INC.
CI-11840-70
In Commercial Distribution

  • 00840180539538 ()


  • Surgical retraction system, reusable

General Instruments - 00840180523773

CC DRILL GUIDE - THREAD IN, 24MM
ALPHATEC SPINE, INC.
CI-11444-24
In Commercial Distribution

  • 00840180523773 ()


  • Surgical drill guide, reusable

General Instruments - 00840180523766

CC DRILL GUIDE - THREAD IN, 22MM
ALPHATEC SPINE, INC.
CI-11444-22
In Commercial Distribution

  • 00840180523766 ()


  • Surgical drill guide, reusable

General Instruments - 00840180523759

CC DRILL GUIDE - THREAD IN, 20MM
ALPHATEC SPINE, INC.
CI-11444-20
In Commercial Distribution

  • 00840180523759 ()


  • Surgical drill guide, reusable

General Instruments - 00840180523742

CC DRILL GUIDE - THREAD IN, 18MM
ALPHATEC SPINE, INC.
CI-11444-18
In Commercial Distribution

  • 00840180523742 ()


  • Surgical drill guide, reusable

Medicrea|UNiD ROD - 03613720289814

UNID EXP B33245699-01 5.5/6.0 CC
MEDICREA INTERNATIONAL
B33245699-01
In Commercial Distribution

  • 03613720289814 ()


  • Bone-screw internal spinal fixation system rod

Medicrea|UNiD ROD - 03613720289753

UNID EXP B33236099-01 6.0 CC DROD
MEDICREA INTERNATIONAL
B33236099-01
In Commercial Distribution

  • 03613720289753 ()


  • Bone-screw internal spinal fixation system rod

AoN Implants - 00840192716446

Ratchet Extraction Key (OUT) - Short - CC
FAICO MEDICAL LLC
AST00SHOEMCRC
Not in Commercial Distribution

  • 00840192716446 ()


  • Dental implant system

AoN Implants - 00840192716439

Ratchet Activation Key (IN) - Short - CC
FAICO MEDICAL LLC
AST00SHOAMCRC
Not in Commercial Distribution

  • 00840192716439 ()


  • Dental implant system

AoN Implants - 00840192702128

Transfer Screw 2 Parts - Short - CC
FAICO MEDICAL LLC
AVR00SHOSN00C
Not in Commercial Distribution

  • 00840192702128 ()


  • Dental implant system

AoN Implants - 00840192702111

Transfer Screw 2 Parts - Long - CC
FAICO MEDICAL LLC
AVR00LNGSN00C
Not in Commercial Distribution

  • 00840192702111 ()


  • Dental implant system

AoN Implants - 00840192701411

Screw Cap h.4 mm. - CC
FAICO MEDICAL LLC
AVT000400000C
Not in Commercial Distribution

  • 00840192701411 ()


  • Dental implant system

AoN Implants - 00840192701404

Screw Cap h.2 mm. - CC
FAICO MEDICAL LLC
AVT000200000C
Not in Commercial Distribution

  • 00840192701404 ()


  • Dental implant system

AoN Implants - 00840192718259

Scanbody Direct Nano Short 3Pod - CC
FAICO MEDICAL LLC
ASBNS00000PPC
Not in Commercial Distribution

  • 00840192718259 ()


  • Dental implant system

AlloFuse® - M536901380051

AlloFuse® DBM Gel, 5 cc
ALLOSOURCE
90138005
In Commercial Distribution

  • M536901380051 ()

  • 5 cc
90138005

  • Bone matrix implant, human-derived

AlloFuse® - M536901380011

AlloFuse® DBM Gel, 1 cc
ALLOSOURCE
90138001
In Commercial Distribution

  • M536901380011 ()

  • 1 cc
90138001

  • Bone matrix implant, human-derived

AlloFuse® - M536900380101

AlloFuse® DBM Putty, 10 cc
ALLOSOURCE
90038010
In Commercial Distribution

  • M536900380101 ()

  • 10 cc
90038010

  • Bone matrix implant, human-derived

AlloFuse® - M536900380051

AlloFuse® DBM Putty, 5 cc
ALLOSOURCE
90038005
In Commercial Distribution

  • M536900380051 ()

  • 5 cc
90038005

  • Bone matrix implant, human-derived

AlloFuse® - M536900380021

AlloFuse® DBM Putty, 2.5 cc
ALLOSOURCE
90038002
In Commercial Distribution

  • M536900380021 ()

  • 2.5 cc
90038002

  • Bone matrix implant, human-derived

AlloFuse® - M536900380011

AlloFuse® DBM Putty, 1 cc
ALLOSOURCE
90038001
In Commercial Distribution

  • M536900380011 ()

  • 1 cc
90038001

  • Bone matrix implant, human-derived

IdentiTi II - 00190376635439

ID II LIF Inserter Sleeve, C-C
ALPHATEC SPINE, INC.
801-140-50
In Commercial Distribution

  • 00190376635439 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

N/A - 00840329814687

TWIST LOCK "HORSESHOE" 60 CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89TL-60CC
In Commercial Distribution

  • 00840329814687 ()
B89TL-60CC

  • Suction/irrigation system canister/bottle holder, reusable

N/A - 00840329814656

TWIST LOCK "HORSESHOE" 20 CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89TL-20CC
In Commercial Distribution

  • 00840329814656 ()
B89TL-20CC

  • Suction/irrigation system canister/bottle holder, reusable

N/A - 00840329814502

SNAP LOCK FOR 60 CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89SL-60CC
In Commercial Distribution

  • 00840329814502 ()
B89SL-60CC

  • Suction/irrigation system canister/bottle holder, reusable

N/A - 00840329814496

SNAP LOCK FOR 35 CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89SL-35CC
In Commercial Distribution

  • 00840329814496 ()
B89SL-35CC

  • Suction/irrigation system canister/bottle holder, reusable

N/A - 00840329814489

SNAP LOCK FOR 30 CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89SL-30CC
In Commercial Distribution

  • 00840329814489 ()
B89SL-30CC

  • Suction/irrigation system canister/bottle holder, reusable
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