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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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NAPA Access System - 10888857553767

C-C Blade, Right 200mm, Ø22
K2M, INC.
8030-90029
In Commercial Distribution

  • 10888857553767 ()
8030-90029

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553750

C-C Blade, Right 190mm, Ø22
K2M, INC.
8030-90028
In Commercial Distribution

  • 10888857553750 ()
8030-90028

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553736

C-C Blade, Right 170mm, Ø22
K2M, INC.
8030-90026
In Commercial Distribution

  • 10888857553736 ()
8030-90026

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553699

C-C Blade, Right 130mm, Ø22
K2M, INC.
8030-90022
In Commercial Distribution

  • 10888857553699 ()
8030-90022

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553675

C-C Blade, Right 110mm, Ø22
K2M, INC.
8030-90020
In Commercial Distribution

  • 10888857553675 ()
8030-90020

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553644

C-C Blade, Right 80mm, Ø22
K2M, INC.
8030-90017
In Commercial Distribution

  • 10888857553644 ()
8030-90017

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553637

C-C Blade, Left 220mm, Ø22
K2M, INC.
8030-90016
In Commercial Distribution

  • 10888857553637 ()
8030-90016

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553613

C-C Blade, Left 200mm, Ø22
K2M, INC.
8030-90014
In Commercial Distribution

  • 10888857553613 ()
8030-90014

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553590

C-C Blade, Left 180mm, Ø22
K2M, INC.
8030-90012
In Commercial Distribution

  • 10888857553590 ()
8030-90012

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553583

C-C Blade, Left 170mm, Ø22
K2M, INC.
8030-90011
In Commercial Distribution

  • 10888857553583 ()
8030-90011

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553576

C-C Blade, Left 160mm, Ø22
K2M, INC.
8030-90010
In Commercial Distribution

  • 10888857553576 ()
8030-90010

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553545

C-C Blade, Left 130mm, Ø22
K2M, INC.
8030-90007
In Commercial Distribution

  • 10888857553545 ()
8030-90007

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553538

C-C Blade, Left 120mm, Ø22
K2M, INC.
8030-90006
In Commercial Distribution

  • 10888857553538 ()
8030-90006

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553514

C-C Blade, Left 100mm, Ø22
K2M, INC.
8030-90004
In Commercial Distribution

  • 10888857553514 ()
8030-90004

  • Surgical retractor/retraction system blade, reusable

NAPA Access System - 10888857553507

C-C Blade, Left 90mm, Ø22
K2M, INC.
8030-90003
In Commercial Distribution

  • 10888857553507 ()
8030-90003

  • Surgical retractor/retraction system blade, reusable

Cortera Spinal Fixation System - 00840311252749

Caddy, IMP, CC Cann, 8.5
Xtant Medical Holdings, Inc.
1509-230080
In Commercial Distribution

  • 00840311252749 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311252732

Caddy, IMP, CC Cann, 4.5
Xtant Medical Holdings, Inc.
1509-230070
In Commercial Distribution

  • 00840311252732 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311247134

Case, Full, Cann, CC, IMP
Xtant Medical Holdings, Inc.
1509-010090
In Commercial Distribution

  • 00840311247134 ()


  • Instrument tray, reusable

General Instruments - 00840180537251

INSIGNIA CC DS GUIDE, SP
ALPHATEC SPINE, INC.
CI-11783-CC15
In Commercial Distribution

  • 00840180537251 ()


  • Surgical drill guide, reusable

General Instruments - 00840180536407

INSIGNIA CC VA DS GUIDE
ALPHATEC SPINE, INC.
CI-11753-CC
In Commercial Distribution

  • 00840180536407 ()


  • Surgical drill guide, reusable

General Instrument - 00840180511718

Modular OCT Screw Tip, CC
ALPHATEC SPINE, INC.
CI-11087-CC
In Commercial Distribution

  • 00840180511718 ()


  • Surgical implant handling forceps

AoN Implants - 00840192701565

2 pieces Transfer - Short - CC
FAICO MEDICAL LLC
ATR00SHOSN00C
Not in Commercial Distribution

  • 00840192701565 ()


  • Dental implant system

AoN Implants - 00840192701558

2 pieces Transfer - Long - CC
FAICO MEDICAL LLC
ATR00LNGSN00C
Not in Commercial Distribution

  • 00840192701558 ()


  • Dental implant system

AoN Implants - 00840192701527

Transfer - h.9 mm. - CC
FAICO MEDICAL LLC
ATR00SHOIP00C
Not in Commercial Distribution

  • 00840192701527 ()


  • Dental implant system

AoN Implants - 00840192701510

Transfer - h.12 mm. - CC
FAICO MEDICAL LLC
ATR00000IP00C
Not in Commercial Distribution

  • 00840192701510 ()


  • Dental implant system

AoN Implants - 00840192717016

OverDLock - h.6 mm. - CC
FAICO MEDICAL LLC
ALK000600000C
Not in Commercial Distribution

  • 00840192717016 ()


  • Dental implant system

AoN Implants - 00840192717009

OverDLock - h.5 mm. - CC
FAICO MEDICAL LLC
ALK000500000C
Not in Commercial Distribution

  • 00840192717009 ()


  • Dental implant system

AoN Implants - 00840192716996

OverDLock - h.4 mm. - CC
FAICO MEDICAL LLC
ALK000400000C
Not in Commercial Distribution

  • 00840192716996 ()


  • Dental implant system

AoN Implants - 00840192716989

OverDLock - h.3 mm. - CC
FAICO MEDICAL LLC
ALK000300000C
Not in Commercial Distribution

  • 00840192716989 ()


  • Dental implant system

AoN Implants - 00840192716972

OverDLock - h.2 mm. - CC
FAICO MEDICAL LLC
ALK000200000C
Not in Commercial Distribution

  • 00840192716972 ()


  • Dental implant system

AoN Implants - 00840192716965

OverDLock - h.1 mm. - CC
FAICO MEDICAL LLC
ALK000100000C
Not in Commercial Distribution

  • 00840192716965 ()


  • Dental implant system

Salvo® Spine System - 10840642139952

Connector, Parallel, C-C, Double, Large
Spine Wave, Inc.
11-7406
In Commercial Distribution

  • 10840642139952 ()
11-7406

  • Bone-screw internal spinal fixation system connector

Salvo® Spine System - 10840642139945

Connector, Parallel, C-C, Double, Medium
Spine Wave, Inc.
11-7405
In Commercial Distribution

  • 10840642139945 ()
11-7405

  • Bone-screw internal spinal fixation system connector

Salvo® Spine System - 10840642139938

Connector, Parallel, C-C, Double, Small
Spine Wave, Inc.
11-7404
In Commercial Distribution

  • 10840642139938 ()
11-7404

  • Bone-screw internal spinal fixation system connector

Acid Etching - 00190746007811

ETCHING SOLUTION LIQUID 14 CC
AMERICAN ORTHODONTICS CORPORATION
001-912
Not in Commercial Distribution

  • 00190746007811 ()
001-912

  • Dental etching solution

Sigma - 00190376316604

120mm C-C Blade, Sigma TLIF
ALPHATEC SPINE, INC.
269-150-120
In Commercial Distribution

  • 00190376316604 ()


  • Surgical retraction system, reusable

Sigma - 00190376316598

110mm C-C Blade, Sigma TLIF
ALPHATEC SPINE, INC.
269-150-110
In Commercial Distribution

  • 00190376316598 ()


  • Surgical retraction system, reusable

Sigma - 00190376316581

100mm C-C Blade, Sigma TLIF
ALPHATEC SPINE, INC.
269-150-100
In Commercial Distribution

  • 00190376316581 ()


  • Surgical retraction system, reusable

Sigma - 00190376316574

90mm C-C Blade, Sigma TLIF
ALPHATEC SPINE, INC.
269-150-090
In Commercial Distribution

  • 00190376316574 ()


  • Surgical retraction system, reusable

Sigma - 00190376316567

80mm C-C Blade, Sigma TLIF
ALPHATEC SPINE, INC.
269-150-080
In Commercial Distribution

  • 00190376316567 ()


  • Surgical retraction system, reusable
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