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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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Acetabular reamer ø38mm - 07630055300454

Acetabular reamer for hip arthroplasty
Incipio Devices SA
9055.IN.038 00
In Commercial Distribution

  • 07630055300454 ()

  • Outer Diameter: 38 Millimeter
9055.IN.038 00

  • Acetabular orthopaedic reamer

Acetabular reamer ø37mm - 07630055300447

Acetabular reamer for hip arthroplasty
Incipio Devices SA
9055.IN.037 00
In Commercial Distribution

  • 07630055300447 ()

  • Outer Diameter: 37 Millimeter
9055.IN.037 00

  • Acetabular orthopaedic reamer

Acetabular reamer ø36mm - 07630055300430

Acetabular reamer for hip arthroplasty
Incipio Devices SA
9055.IN.036 00
In Commercial Distribution

  • 07630055300430 ()

  • Outer Diameter: 36 Millimeter
9055.IN.036 00

  • Acetabular orthopaedic reamer

Dupress® - 00809958092620

9 in X 9 in, 8-ply Burn dressing. Bundled and packaged in 10s. Sterile.
Derma Sciences Canada Inc
9825
In Commercial Distribution

  • 00809958092620 ()
  • 00809958092606 ()

  • 9 in X 9 in
  • 23 cm X 23 cm
DUP9825

  • Non-woven gauze pad

Plasma-Cel Roll - 00843356101447

Plasma-Cel Roll (1/4 in.) 12 in. x 72 in. - 4 rolls per bag
CYGNUS MEDICAL L.L.C.
PC4614
In Commercial Distribution

  • 10843356101444 ()
  • 00843356101447 ()
  • 30843356101448 ()


  • Surgical instrument guard, single-use

McKesson - 00612479221154

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 20 in x 18 in x 3 in
MCKESSON MEDICAL-SURGICAL INC.
170-74014
In Commercial Distribution

  • 00612479221161 ()
  • 00612479221154 ()


  • Wheelchair seat cushion

McKesson - 00612479221130

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 20 in x 16 in x 3 in
MCKESSON MEDICAL-SURGICAL INC.
170-74004
In Commercial Distribution

  • 00612479221147 ()
  • 00612479221130 ()


  • Wheelchair seat cushion

McKesson - 00612479221116

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 18 in x 18 in x 3 in
MCKESSON MEDICAL-SURGICAL INC.
170-74003
In Commercial Distribution

  • 00612479221123 ()
  • 00612479221116 ()


  • Wheelchair seat cushion

McKesson - 00612479221093

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 18 in x 16 in x 3 in
MCKESSON MEDICAL-SURGICAL INC.
170-74002
In Commercial Distribution

  • 00612479221109 ()
  • 00612479221093 ()


  • Wheelchair seat cushion

McKesson - 00612479221079

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 16 in x 16 in x 3 in
MCKESSON MEDICAL-SURGICAL INC.
170-74001
In Commercial Distribution

  • 00612479221086 ()
  • 00612479221079 ()


  • Wheelchair seat cushion

McKesson - 00612479221055

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 22 in x 18 in x 2 in
MCKESSON MEDICAL-SURGICAL INC.
170-73005
In Commercial Distribution

  • 00612479221062 ()
  • 00612479221055 ()


  • Wheelchair seat cushion

McKesson - 00612479221031

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 20 in x 16 in x 2 in
MCKESSON MEDICAL-SURGICAL INC.
170-73003
In Commercial Distribution

  • 00612479221048 ()
  • 00612479221031 ()


  • Wheelchair seat cushion

McKesson - 00612479221017

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 18 in x 16 in x 2 in
MCKESSON MEDICAL-SURGICAL INC.
170-73002
In Commercial Distribution

  • 00612479221024 ()
  • 00612479221017 ()


  • Wheelchair seat cushion

McKesson - 00612479220997

Gel Cushion HIGH DENSITY POLYURETHANE FOAM 16 in x 16 in x 2 in
MCKESSON MEDICAL-SURGICAL INC.
170-73001
In Commercial Distribution

  • 00612479221000 ()
  • 00612479220997 ()


  • Wheelchair seat cushion

Marina Medical - 00840306828249

Scope Tray 18 in. x 6.5 in. x 3 in., Tray, Lid and Bars
MARINA MEDICAL INSTRUMENTS, INC.
300-203
In Commercial Distribution

  • 00840306828249 ()

  • Length: 18 Inch
300-203

  • Surgical tray stand

Symmetry Surgical® - 00887482144398

Tray, Sterilization, 15 in x 10 1/2 in x 3 1/2 in
SYMMETRY SURGICAL INC.
20-1015
Not in Commercial Distribution

  • 00887482144398 ()
20-1015

  • Instrument tray, reusable

Symmetry Surgical® - 00887482144374

Tray, Sterilization, 10 in x 6 1/2 in x 2 1/2 in
SYMMETRY SURGICAL INC.
20-1006X
Not in Commercial Distribution

  • 00887482144374 ()
20-1006X

  • Instrument tray, reusable

Symmetry Hibbs - 00887482045053

Symmetry® Retractor, Hibbs, 3 in Deep, 1 in Wide, 9 3/4 in
SYMMETRY SURGICAL INC.
23-6381
In Commercial Distribution

  • 00887482045053 ()

  • Length: 9.75 Inch
23-6381

  • Hand-held surgical retractor, reusable

Symmetry - 00887482057148

Tray, Perforated Mayo, 17 in x 11 5/8 in x 3/4 in
SYMMETRY SURGICAL INC.
17F-PMT
In Commercial Distribution

  • 00887482057148 ()

  • Length: 17 Inch
  • Width: 11.625 Inch
  • Height: 0.75 Inch
17F-PMT

  • Sterilization stringer

Integra® - 10381780246442

PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 40
Ascension Orthopedics, Inc.
OSG20040P
In Commercial Distribution

  • M269OSG20040P1 ()
  • 10381780246442 ()

  • Size 40; 1.250 in L x .966 in outer W x .27 in inner W
OSG-200-40P

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246428

PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 30
Ascension Orthopedics, Inc.
OSG20030P
In Commercial Distribution

  • M269OSG20030P1 ()
  • 10381780246428 ()

  • Size 30; 1.250 in L x .926 in outer W x .25 in inner W
OSG-200-30P

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246404

PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 20
Ascension Orthopedics, Inc.
OSG20020P
In Commercial Distribution

  • M269OSG20020P1 ()
  • 10381780246404 ()

  • Size 20; 1.250 in L x .879 in outer W x .23 in inner W
OSG-200-20P

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246381

PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 10
Ascension Orthopedics, Inc.
OSG20010P
In Commercial Distribution

  • M269OSG20010P1 ()
  • 10381780246381 ()

  • Size 10; 1.225 in L x .814 in outer W x .19 in inner W
OSG-200-10P

  • Custom-made orthopaedic/craniofacial surgical guide

Symmetry Surgical® - 00887482049860

Speculum, Sims Vaginal, Double-Ended, #1, 1 in x 2 3/4 in x 1 1/8 in x 3 in
SYMMETRY SURGICAL INC.
52-2001
Not in Commercial Distribution

  • 00887482049860 ()
52-2001

  • Vaginal speculum, reusable

RONDEX CPR REDI-SHIELD (Made in USA) in key ring case with gloves - 00634376098578

The RONDEX CPR REDI-SHIELD model #9850-G comes in a case with a key ring and gloves. It is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9850-G (packaged in key ring case)
In Commercial Distribution

9850-G

  • Cardiopulmonary resuscitation mask, single-use

Integra® - 10381780248026

Integra® External Fixation System The AO t-handle is used in conjunction with the external fixation system.
Ascension Orthopedics, Inc.
5010001000
In Commercial Distribution

  • M26950100010001 ()
  • 10381780248026 ()

  • 4.399 in L handle
5010001000

  • Surgical instrument handle, non-torque-limiting

Construct ™ - 10381780246572

Construct® Ankle Fusion Plate System The depth gauge for plate screws is a tool used to measure the required depth of a drilled hole.
Ascension Orthopedics, Inc.
PDG-5010-01
Not in Commercial Distribution

  • M269PDG5010011 ()
  • 10381780246572 ()

  • .044 in W tip
PDG501001

  • Surgical depth gauge, reusable

Integra® - 10381780245735

Modular Radial Head Impactor, Stem, MRH
Ascension Orthopedics, Inc.
IMP35000
In Commercial Distribution

  • M269IMP350001 ()
  • 10381780245735 ()

  • .375 in inner dia
IMP-350-00

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245438

Titan™ Reverse Shoulder System The glenoid wire guide is used to determine proper guide pin positioning.
Ascension Orthopedics, Inc.
GWG096005301
In Commercial Distribution

  • M269GWG0960053011 ()
  • 10381780245438 ()

  • 7.0 in L handle
GWG-0960-053-01

  • Orthopaedic guidewire, reusable

Titan™ - 10381780245421

Titan™ Reverse Shoulder System The glenoid wire guide is eccentric with a lip and is used to determine proper guide pin positioning.
Ascension Orthopedics, Inc.
GWG0960050EL
In Commercial Distribution

  • M269GWG0960050EL1 ()
  • 10381780245421 ()

  • 7.0 in L handle
GWG-0960-050-EL

  • Orthopaedic guidewire, reusable

Titan™ - 10381780245414

Titan™ Reverse Shoulder System The glenoid wire guide is concentric with a lip and is used to determine proper guide pin positioning.
Ascension Orthopedics, Inc.
GWG0960050CL
In Commercial Distribution

  • M269GWG0960050CL1 ()
  • 10381780245414 ()

  • 7.0 in L handle
GWG-0960-050-CL

  • Orthopaedic guidewire, reusable

Ti6® Internal Fixation System - 10381780245094

Integra® Ti6® The Ti6 CounterSink is used to add space or clearance for the head of a TS-Series 3.0 or 4.0mm screw with AO.
Ascension Orthopedics, Inc.
FS2085
In Commercial Distribution

  • M269FS20851 ()
  • 10381780245094 ()

  • Large; 3.865 in L
FS2085

  • Surgical screwdriver, reusable

Ti6® Internal Fixation System - 10381780245063

Integra® Ti6® The Ti6 CounterSink is used to add space or clearance for the head of a TS-Series 2.0 or 2.5mm screw.
Ascension Orthopedics, Inc.
FS2070
In Commercial Distribution

  • M269FS20701 ()
  • 10381780245063 ()

  • Small; 3.75 in L
FS2070

  • Surgical screwdriver, reusable

Ti6® Internal Fixation System - 10381780245032

Integra® Ti6® The TS-Series depth gauge for 3.0/4.0 mm screws is a tool used to measure the depth of a drilled hole.
Ascension Orthopedics, Inc.
FS2040
In Commercial Distribution

  • M269FS20401 ()
  • 10381780245032 ()

  • 1.87 in L probe
FS2040

  • Surgical depth gauge, reusable

Ti6® Internal Fixation System - 10381780245025

Integra® Ti6® The TS-Series depth gauge for 2.0/2.5 mm screws is a tool used to measure the depth of a drilled hole.
Ascension Orthopedics, Inc.
FS2030
In Commercial Distribution

  • M269FS20301 ()
  • 10381780245025 ()

  • 2.074 in L probe
FS2030

  • Surgical depth gauge, reusable

Titan™ - 10381780247425

Titan™ Total Shoulder System The body separator is used in the removal of the proximal humeral body.
Ascension Orthopedics, Inc.
SP0920068001
In Commercial Distribution

  • M269SEP09200680011 ()
  • 10381780247425 ()

  • 9.33 in L caliper
SEP-0920-068-001

  • Orthopaedic inorganic implant inserter/extractor, reusable

Titan™ - 10381780244585

Titan™ Total Shoulder System The solid center starter drill is used with the total shoulder system.
Ascension Orthopedics, Inc.
DL0920056001
In Commercial Distribution

  • M269DRL09200560011 ()
  • 10381780244585 ()

  • .195 in W tip
DRL-0920-056-001

  • Cannulated surgical drill bit, single-use

Titan™ - 10381780244578

Titan™ Total Shoulder System The cannulated peg drill is used with the total shoulder system.
Ascension Orthopedics, Inc.
DL0920047002
In Commercial Distribution

  • M269DRL09200470021 ()
  • 10381780244578 ()

  • .207 in W tip
DRL-0920-047-002

  • Cannulated surgical drill bit, single-use

Titan™ - 10381780244561

Titan™ Total Shoulder System The cannulated center starter drill is used with the total shoulder system.
Ascension Orthopedics, Inc.
DL0920047001
In Commercial Distribution

  • M269DRL09200470011 ()
  • 10381780244561 ()

  • .195 in W tip
DRL-0920-047-001

  • Cannulated surgical drill bit, single-use

Integra® - 10381780242680

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
BRH90000
In Commercial Distribution

  • M269BRH900001 ()
  • 10381780242680 ()

  • .924 in L tip
BRH-900-00

  • Orthopaedic broach

CONMED - 20845854050290

4K UHD MONITOR, 32 IN, 81 CM
Conmed Corporation
VP4932
In Commercial Distribution

  • 10845854050293 ()
  • 20845854050290 ()

  • 32 IN, 81 CM
VP4932

  • Image display unit, colour

CUSTOMED - M20890040522

CUSTOMED DISPOSABLE UNDERPADS 30 X 70 IN
CUSTOMED INC
712057104052
In Commercial Distribution

  • M20890040520 ()
  • M20890040522 ()

  • 30 X 70 IN
9004052

  • Absorbent underpad, non-antimicrobial, single-use

CUSTOMED - M20890031442

CUSTOMED UNDERPADS 23" X 36" , 15/BAG, 10BAG/CS
CUSTOMED INC
712057103144
In Commercial Distribution

  • M20890031440 ()
  • M20890031442 ()

  • 23 X 36 IN
9003144

  • Absorbent underpad, non-antimicrobial, single-use

CUSTOMED - M20890030932

CUSTOMED DISPOSABLE UNDERPADS 30 X 36 IN
CUSTOMED INC
712057103093
In Commercial Distribution

  • M20890030930 ()
  • M20890030932 ()

  • 30 X 36 IN
9003093

  • Absorbent underpad, non-antimicrobial, single-use

CUSTOMED - M20890030922

CUSTOMED DISPOSABLE UNDERPADS 23 X 36 IN
CUSTOMED INC
712057103092
In Commercial Distribution

  • M20890030920 ()
  • M20890030922 ()

  • 23 x 36 IN
9003092

  • Absorbent underpad, non-antimicrobial, single-use

DRILL BIT QUICK RELEASE - 00887868101670

No Description
Biomet Orthopedics, LLC
35-463020
In Commercial Distribution

  • 00887868101670 ()

  • 4.5 X 5 IN
35-463020

  • Fluted surgical drill bit, single-use

TITAN™ - 10381780258322

Angled Handle
Ascension Orthopedics, Inc.
HDL-0926-001
In Commercial Distribution

  • M269HDL09260011 ()
  • 10381780258322 ()

  • 3.4 in L rod


  • Orthopaedic implant-instrument extension adaptor, reusable

DuCare® - 00809958030318

1 in Single Strugn Tonsil Sponge. X-Ray detectable
Derma Sciences Canada Inc
3052
In Commercial Distribution

  • 00809958030318 ()

  • 1 in
  • 2.5 cm
DUP3052

  • Radiopaque woven surgical sponge

Derma Sciences - 00809958074411

6 in Flannel Bandage. Sterile.
Derma Sciences Canada Inc
77884
In Commercial Distribution

  • 00809958074411 ()

  • 15 cm
  • 6 in
DUP77884

  • Woven gauze roll/sheet

Titan™ - 10381780124573

The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP-0923-070-001E
In Commercial Distribution

  • M269HSP0923070001E1 ()
  • 10381780124573 ()

  • Size38-E; 1.5 in dia
HSP-0923-070-001E

  • Surgical implant template, reusable
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