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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Pharmacy Refrigerator, 11 cu ft
HELMER, INC.
iPR111
In Commercial Distribution

  • 00816394020346 ()


  • Blood refrigerator
Laboratory Refrigerator, 11 cu ft
HELMER, INC.
HLR111
In Commercial Distribution

  • 00816394020278 ()


  • Blood refrigerator
Gel Pack 11" x 24"
VIVE HEALTH LLC
RHB2001
In Commercial Distribution

  • 10818323028482 ()
  • 00818323028485 ()


  • Ice bag
Gel Pack 11" x 24"
VIVE HEALTH LLC
RHB2001
In Commercial Distribution

  • 10818323028376 ()
  • 00818323028379 ()


  • Hot/cold therapy pack, reusable
Blade Femoral Broach Size 11
NEXTSTEP ARTHROPEDIX, LLC
10-80-0311
In Commercial Distribution

  • 00816127028786 ()


  • Orthopaedic broach
Femoral Stem, Size 11, Lateralized
NEXTSTEP ARTHROPEDIX, LLC
10-11-0011
In Commercial Distribution

  • 00816127022180 ()

  • Length: 136 Millimeter
10-11-0011

  • Press-fit hip femur prosthesis, modular
Femoral Stem, Size 11, Standard
NEXTSTEP ARTHROPEDIX, LLC
10-10-0011
In Commercial Distribution

  • 00816127022043 ()

  • Length: 136 Millimeter
10-10-0011

  • Press-fit hip femur prosthesis, modular
Neck Trial, Size 11, Lateral
NEXTSTEP ARTHROPEDIX, LLC
10-81-0211
In Commercial Distribution

  • 00816127020421 ()


  • Femoral stem prosthesis trial
Neck Trial, Size 11, Standard
NEXTSTEP ARTHROPEDIX, LLC
10-81-0111
In Commercial Distribution

  • 00816127020278 ()


  • Femoral stem prosthesis trial
CUSHING NERVE HOOK #1 11"
SKLAR CORPORATION
50-1309
In Commercial Distribution

  • 10649111079184 ()


  • Nerve/vessel retractor
SIZE 11 LEG, GLENOID TARGETER
ARTHREX, INC.
AR-5400-11
In Commercial Distribution

  • 00888867315389 ()
AR-5400-11

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Laboratory Refrigerator, 11 cu ft
HELMER, INC.
iLR111
In Commercial Distribution

  • 00816394020209 ()


  • Blood refrigerator
CTA CUT GUIDE, SIZE 11
ARTHREX, INC.
AR-9200-21CA
In Commercial Distribution

  • 00888867136977 ()
AR-9200-21CA

  • Surgical drill guide, reusable
STEM EXTENSION TRIAL-BOWED 11/150
DEPUY ORTHOPAEDICS, INC.
2987-15-211
In Commercial Distribution

  • 10603295157878 ()
298715211

  • Knee femur prosthesis trial, reusable
RAMUS, OBWEGESER, 11 MM TIP
KLS-Martin L.P.
48-150-02-07
In Commercial Distribution

  • 00888118070845 ()

  • 17.5 CM


  • Bone file/rasp, manual, reusable
BR4111-119-090 90 X 11 MM
Peter Brasseler Holdings, LLC
5025244M0
In Commercial Distribution

  • 00887919748014 ()


  • Surgical saw blade, oscillating, single-use
11 inch Switching Stick, 3.5mm
Surgical Direct, Inc.
SD48-10150
In Commercial Distribution

  • B382SD48101500 ()
SD48-10150

  • Laparoscopic access cannula, reusable
ACTERA FEMORAL BROACH, SIZE 11
Conformis, Inc.
1080-686
In Commercial Distribution

  • 00810933031541 ()
1080-686

  • Orthopaedic broach
OSStaple 11 x 08 W1.5
Biomedical Enterprises, Inc.
OS-1108W1.5
In Commercial Distribution

  • 00810633021064 ()

  • Length: 08 Millimeter
  • Width: 11 Millimeter


  • Orthopaedic bone staple, non-adjustable
SCISSOR METZENBAUM CURVED TC 11"
Princeton Medical Group, Inc.
09285-28
In Commercial Distribution

  • 00810158215627 ()


  • Dressing/utility forceps, scissors-like, reusable
RETRACTOR RICHARDSON-EASTMAN 49X38MM / 71X43MM 11"
Princeton Medical Group, Inc.
19140-02
In Commercial Distribution

  • 00810158213463 ()


  • Periocular/lacrimal retractor, hand-held, reusable
FORCEPS BIOPSY SCHUBERT STRAIGHT 11"
Princeton Medical Group, Inc.
71604-28
In Commercial Distribution

  • 00810158212046 ()


  • ENT soft-tissue cutting forceps
FORCEPS MIXTER HEMOSTATIC LONGITUDINAL 11"
Princeton Medical Group, Inc.
13479-28
In Commercial Distribution

  • 00810158211803 ()


  • ENT soft-tissue cutting forceps
Specialty Spacer Shim 11 MM
Howmedica Osteonics Corp.
I-K4204SS11
In Commercial Distribution

  • 07613327473247 ()

  • Height: 11.0 Millimeter
I-K4204SS11

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Specialty Spacer Shim 11 MM
Howmedica Osteonics Corp.
I-K4204SL11
In Commercial Distribution

  • 07613327473124 ()

  • Height: 11.0 Millimeter
I-K4204SL11

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PRESS-FIT TIBIAL PUNCH-SIZE #11/13
Howmedica Osteonics Corp.
3760-1113
In Commercial Distribution

  • 07613327222708 ()

  • Size: 11
  • Size: 13
3760-1113

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SIMON VAGINAL RETR 115X22MM 11"
Surgipros, LLC
EL872SP
In Commercial Distribution

  • 00810143902297 ()


  • Vaginal speculum, reusable
DRILL, 11 MM, REAMER, DISPOSABLE
Kalitec Direct LLC
07-ADD-1111
In Commercial Distribution

  • B07307ADD11111 ()
074-ADD-1111

  • Fluted surgical drill bit, single-use, non-sterile
DRILL, 11 MM, HELICAL, DISPOSABLE
Kalitec Direct LLC
07-ADD-1011
In Commercial Distribution

  • B07307ADD10111 ()
07-ADD-1011

  • Fluted surgical drill bit, single-use, non-sterile
Trial 16*18mm,20°-11
Zsfab, Inc.
16181120
In Commercial Distribution

  • 00810136251890 ()

  • Depth: 16 Millimeter
  • Width: 18 Millimeter
  • Height: 11 Millimeter
  • Angle: 20 degree


  • Metallic spinal interbody fusion cage
Trial 16*18mm,15°-11
Zsfab, Inc.
16181115
In Commercial Distribution

  • 00810136251845 ()

  • Depth: 16 Millimeter
  • Width: 18 Millimeter
  • Height: 11 Millimeter
  • Angle: 15 degree


  • Metallic spinal interbody fusion cage
Trial 16*18mmm,10°-11
Zsfab, Inc.
16181110
In Commercial Distribution

  • 00810136251784 ()

  • Depth: 16 Millimeter
  • Width: 18 Millimeter
  • Height: 11 Millimeter
  • Angle: 10 degree


  • Metallic spinal interbody fusion cage
Trial 16*18mm,7°-11
Zsfab, Inc.
16181107
In Commercial Distribution

  • 00810136251715 ()

  • Depth: 16 Millimeter
  • Width: 18 Millimeter
  • Height: 11 Millimeter
  • Angle: 7 degree


  • Metallic spinal interbody fusion cage
Trial 16*18mm,0°-11
Zsfab, Inc.
16181100
In Commercial Distribution

  • 00810136251630 ()

  • Depth: 16 Millimeter
  • Width: 18 Millimeter
  • Height: 11 Millimeter
  • Angle: 0 degree


  • Metallic spinal interbody fusion cage
Trial 14*16mm,15°-11
Zsfab, Inc.
14161115
In Commercial Distribution

  • 00810136251500 ()

  • Depth: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 11 Millimeter
  • Angle: 15 degree


  • Metallic spinal interbody fusion cage
Trial 12*14mm,15°-11
Zsfab, Inc.
12141115
In Commercial Distribution

  • 00810136251135 ()

  • Depth: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 11 Millimeter
  • Angle: 15 degree


  • Metallic spinal interbody fusion cage
Trial 12*14mm,10°-11
Zsfab, Inc.
12141110
In Commercial Distribution

  • 00810136251067 ()

  • Depth: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 11 Millimeter
  • Angle: 10 degree


  • Metallic spinal interbody fusion cage
Trial 12*14mm,7°-11
Zsfab, Inc.
12141107
In Commercial Distribution

  • 00810136250985 ()

  • Depth: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 11 Millimeter
  • Angle: 7 degree


  • Metallic spinal interbody fusion cage
Trial 14*16mm,20°-11
Zsfab, Inc.
14161120
In Commercial Distribution

  • 00810136251555 ()

  • Depth: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 11 Millimeter
  • Angle: 20 degree


  • Metallic spinal interbody fusion cage
Trial 14*16mm,10°-11
Zsfab, Inc.
14161110
In Commercial Distribution

  • 00810136251432 ()

  • Depth: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 11 Millimeter
  • Angle: 10 degree


  • Metallic spinal interbody fusion cage
Trial 14*16mm,0°-11
Zsfab, Inc.
14161100
In Commercial Distribution

  • 00810136251272 ()

  • Depth: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 11 Millimeter
  • Angle: 0 degree


  • Metallic spinal interbody fusion cage
Trial 12*14mm,20°-11
Zsfab, Inc.
12141120
In Commercial Distribution

  • 00810136251197 ()

  • Depth: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 11 Millimeter
  • Angle: 20 degree


  • Metallic spinal interbody fusion cage
Trial 12*14mm,0°-11
Zsfab, Inc.
12141100
In Commercial Distribution

  • 00810136250909 ()

  • Depth: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 11 Millimeter
  • Angle: 0 degree


  • Metallic spinal interbody fusion cage
PELHAM - Crystal - 59 * 11 - 145
Fade To Grey Corp.
Pelham-Crystal
In Commercial Distribution

  • G131PELHAMCR0 ()
  • 00810110313507 ()


  • Spectacle frame
PELHAM - Cognac - 59 * 11 - 145
Fade To Grey Corp.
Pelham-Cognac
In Commercial Distribution

  • G131PELHAMCGN0 ()
  • 00810110313484 ()


  • Spectacle frame
PELHAM - Blue - 59 * 11 - 145
Fade To Grey Corp.
Pelham-Blue
In Commercial Distribution

  • G131PELHAMBL0 ()
  • 00810110313460 ()


  • Spectacle frame
IP TEMP CEMENT 1-1 SET
SHOFU DENTAL CORPORATION
1197
In Commercial Distribution

  • E23511970 ()
1197

  • Glass ionomer dental cement
SureMAX-SA — 7° Extra–Large 11
ADDITIVE IMPLANTS, LLC
1
In Commercial Distribution

  • 00817662025056 ()
1022-07152011

  • Metallic spinal interbody fusion cage
Curaplex 11 Point Bridle Strap
BOUND TREE MEDICAL, LLC
3020-28013
In Commercial Distribution

  • 00817617025094 ()
  • 00817617025032 ()
3020-28013

  • Limb/torso/head restraint, reusable
KUNTSCHER PT AWL 10MM 11"
SKLAR CORPORATION
40-1628
In Commercial Distribution

  • 10649111088834 ()


  • Bone awl, reusable
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