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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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CEKA & PRECI-LINE ATTACHMENTS - 04260576943231

PRECI-POST CC REAMER B 1 P.
Alphadent NV
2952B
In Commercial Distribution

  • 04260576943231 ()

  • Outer Diameter: 0.7 Millimeter
2952B

  • Root canal post kit

CEKA & PRECI-LINE ATTACHMENTS - 04260576943224

PRECI-POST CC REAMER A 1 P.
Alphadent NV
2951A
In Commercial Distribution

  • 04260576943224 ()

  • Outer Diameter: 0.65 Millimeter
2951A

  • Root canal post kit

Cortera Spinal Fixation System - 00840311252152

Case ASM, IMP, CC Cann, 8.5
Xtant Medical Holdings, Inc.
1509-200160
In Commercial Distribution

  • 00840311252152 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311252145

Case ASM, IMP, CC Cann, 4.5
Xtant Medical Holdings, Inc.
1509-200150
In Commercial Distribution

  • 00840311252145 ()


  • Instrument tray, 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

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

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

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

Bandtite Band Cement - 00190746007866

BANDTITE GLASS IONOMER LIQUID 60 CC
AMERICAN ORTHODONTICS CORPORATION
001-971
In Commercial Distribution

  • 00190746007866 ()
001-971

  • Orthodontic bracket adhesive

Gen2 - 00840343715557

CC SPINAL CURETTE STR 10'' 3
SURGIX MEDICAL LLC
G2N87408
In Commercial Distribution

  • 00840343715557 ()

  • Length: 10 Inch
  • Tip Size 3 Size
  • Direction Straight
G2N87408

  • Bone curette, 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

N/A - 00840329814472

SNAP LOCK FOR 20 CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89SL-20CC
In Commercial Distribution

  • 00840329814472 ()
B89SL-20CC

  • Suction/irrigation system canister/bottle holder, reusable

N/A - 00840329814465

SNAP LOCK FOR 10 CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89SL-10CC
In Commercial Distribution

  • 00840329814465 ()
B89SL-10CC

  • Suction/irrigation system canister/bottle holder, 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

IdentiTi - 00190376396279

ALIF, ENDPLATE SCRAPER, CC OFFSET, 22mm
ALPHATEC SPINE, INC.
168-13-100-22
In Commercial Distribution

  • 00190376396279 ()


  • Bone cutter

IdentiTi - 00190376396262

ALIF, ENDPLATE SCRAPER, CC OFFSET, 20mm
ALPHATEC SPINE, INC.
168-13-100-20
In Commercial Distribution

  • 00190376396262 ()


  • Bone cutter

IdentiTi - 00190376396255

ALIF, ENDPLATE SCRAPER, CC OFFSET, 18mm
ALPHATEC SPINE, INC.
168-13-100-18
In Commercial Distribution

  • 00190376396255 ()


  • Bone cutter

IdentiTi - 00190376396248

ALIF, ENDPLATE SCRAPER, CC OFFSET, 16mm
ALPHATEC SPINE, INC.
168-13-100-16
In Commercial Distribution

  • 00190376396248 ()


  • Bone cutter

IdentiTi - 00190376396231

ALIF, ENDPLATE SCRAPER, CC OFFSET, 14mm
ALPHATEC SPINE, INC.
168-13-100-14
In Commercial Distribution

  • 00190376396231 ()


  • Bone cutter
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