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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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Persona® - 00889024557918

No Description
Zimmer, Inc.
42-5892-005-30
In Commercial Distribution

  • 00889024557918 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / C, D
42-5892-005-30

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557840

No Description
Zimmer, Inc.
42-5891-009-30
In Commercial Distribution

  • 00889024557840 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / G, H
42-5891-009-30

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557826

No Description
Zimmer, Inc.
42-5891-007-30
In Commercial Distribution

  • 00889024557826 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / E, F
42-5891-007-30

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557802

No Description
Zimmer, Inc.
42-5891-005-30
In Commercial Distribution

  • 00889024557802 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / C, D
42-5891-005-30

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557734

No Description
Zimmer, Inc.
42-5892-009-20
In Commercial Distribution

  • 00889024557734 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / G, H
42-5892-009-20

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557710

No Description
Zimmer, Inc.
42-5892-007-20
In Commercial Distribution

  • 00889024557710 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / E, F
42-5892-007-20

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557697

No Description
Zimmer, Inc.
42-5892-005-20
In Commercial Distribution

  • 00889024557697 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / C, D
42-5892-005-20

  • Knee tibia prosthesis trial, reusable

MatriStem - 00386190000533

Pelvic Floor Matrix 9 x 12 cm
ACELL, INC.
PFM0912
Not in Commercial Distribution

  • 00386190000533 ()

  • Trapezodial device approximately 9 x 9 x 12 cm
PFM0912

  • Pelvic organ prolapse/stress urinary incontinence surgical mesh

HemCon® ChitoPulse™, 9 inch - 00870053000063

ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowing gradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053000063 ()
  • 20870053000067 ()
  • 50870053000068 ()
1095

  • Radial artery compression device

Pneumococcus Group 9 serum, 1 mL - 05713106169032

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
16903
In Commercial Distribution

  • 05713106169032 ()
16903

  • Streptococcus pneumoniae culture isolate antigen IVD, antibody

CANNULATED HEX DRIVER 7.1mm (9/32") - 00848665001877

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0441
In Commercial Distribution

  • 00848665001877 ()


  • Surgical screwdriver, reusable

SINUS INSTRUMENT #9 CH S/E - D9281051999SECH0

No Description
W.H. Holden, Inc.
10-5199-9SECH
In Commercial Distribution

  • D9281051999SECH0 ()


  • Dental osteotome set

SINUS INSTRUMENT #9 CH D/E - D9281051999CH0

No Description
W.H. Holden, Inc.
10-5199-9CH
In Commercial Distribution

  • D9281051999CH0 ()


  • Dental osteotome set

CURETTE BONE #9 D/E SPECIAL - D928105109NAPAV0

No Description
W.H. Holden, Inc.
10-5109NAPAV
In Commercial Distribution

  • D928105109NAPAV0 ()


  • Bone curette, reusable

CURETTE BONE #9 HF D/E - D928105109HF0

No Description
W.H. Holden, Inc.
10-5109HF
In Commercial Distribution

  • D928105109HF0 ()


  • Bone curette, reusable

CURETTE BONE #9 HD D/E - D928105109HD0

No Description
W.H. Holden, Inc.
10-5109HD
In Commercial Distribution

  • D928105109HD0 ()


  • Bone curette, reusable

CURETTE BONE #9 CH D/E - D928105109CH0

No Description
W.H. Holden, Inc.
10-5109CH
In Commercial Distribution

  • D928105109CH0 ()


  • Bone curette, reusable

CURETTE BONE #9 D/E BARTEE - D928105109B0

No Description
W.H. Holden, Inc.
10-5109B
In Commercial Distribution

  • D928105109B0 ()


  • Bone curette, reusable

SINUS INSTRUMENT #9 HD D/E - D9281051999HD0

No Description
W.H. Holden, Inc.
10-5199-9HD
In Commercial Distribution

  • D9281051999HD0 ()


  • Dental osteotome set

Osteotec Silicone Finger Implant - Size 9 - 05060183090101

The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty.
OSTEOTEC LIMITED
OSTF-9
In Commercial Distribution

  • 05060183090101 ()
OSTF-9

  • Metacarpophalangeal/proximal interphalangeal joint prosthesis

SUCTION TIP ANDREW-PINCHON. 9 IN. LENGTH - D9281061050

No Description
W.H. Holden, Inc.
10-6105
In Commercial Distribution

  • D9281061050 ()


  • Dental suction system cannula, reusable

SUCTION TIP BARBEE, 9 IN. LENGTH - D9281061020

No Description
W.H. Holden, Inc.
10-6102
In Commercial Distribution

  • D9281061020 ()


  • Dental suction system cannula, reusable

Trach Tube Holder - Pediatric (9" length) - 00616784462134

No Description
Dynarex Corporation
4621
In Commercial Distribution

  • 00616784462134 ()
  • 00616784462110 ()


  • Tracheostomy tube neck holder, reusable

Origin TT Stem, Broach, Size 9 - 09348215137793

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
591-009
In Commercial Distribution

  • 09348215137793 ()


  • Orthopaedic broach

Origin TT High Offset Size 9 - 09348215137663

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
59-0109
In Commercial Distribution

  • 09348215137663 ()


  • Coated hip femur prosthesis, modular

Origin TT Standard Offset Size 9 - 09348215137533

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
59-0009
In Commercial Distribution

  • 09348215137533 ()


  • Coated hip femur prosthesis, modular

Multistix® 9 SG Reagent Strips - 00630414549026

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and bilirubin
Siemens Healthcare Diagnostics Inc.
10337216
In Commercial Distribution

  • 00630414549026 ()
  • 00630414009681 ()
A2163B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Distal Reduces Aria Broach Size 9 - 09348215073435

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-20-6909
In Commercial Distribution

  • 09348215073435 ()


  • Orthopaedic broach

9" ABDOMINAL BINDER UP TO 45" - 00610570107261

No Description
Bird & Cronin, LLC
BC 0345
In Commercial Distribution

  • 00610570107261 ()


  • Abdominal binder, single-use

9" ABD W/DRAIN HLDR 55-72" - 00610570157853

No Description
Bird & Cronin, LLC
08148228
In Commercial Distribution

  • 00610570157853 ()


  • Wearable percutaneous catheter/tube holder

9" ABD W/DRAIN HLDR 46-62" - 00610570157846

No Description
Bird & Cronin, LLC
08148227
In Commercial Distribution

  • 00610570157846 ()


  • Wearable percutaneous catheter/tube holder

PANACEA CONVERTIBLE PLUS 9 CELL MATTRESS - 00845699007981

No Description
SIZEWISE RENTALS, L.L.C.
PANACEA CONVERTIBLE PLUS 9 CELL MATTRESS
In Commercial Distribution

  • 00845699007981 ()


  • Alternating-pressure bed mattress

ALKALINE WASH SOLUTION (WASH soln. 9) - 05055273215007

Alkaline Wash Solution should be used in conjunction with reagents to clean cuvettes
RANDOX LABORATORIES LIMITED
RX8130
In Commercial Distribution

  • 05055273215007 ()
RX8130

  • Wash/cleaning solution IVD, automated/semi-automated system

DMEM/F12 Baxter Special 9, 100L - 05407010126501

No Description
Lonza Verviers
BESP845J
In Commercial Distribution

  • 05407010126501 ()
BESP845J

  • Ex vivo cell culture medium

DMEM/F12 Baxter Special 9, 5L - 05407010126495

No Description
Lonza Verviers
BESP845B
In Commercial Distribution

  • 05407010126495 ()
BESP845B

  • Ex vivo cell culture medium

DMEM/F12 Baxter Special 9, 1L - 05407010127003

No Description
Lonza Verviers
BESP845B1
In Commercial Distribution

  • 05407010127003 ()
BESP845B1

  • Ex vivo cell culture medium

DMEM/F12 Baxter Special 9, 500L - 05407010126617

No Description
Lonza Verviers
BESP845L
In Commercial Distribution

  • 05407010126617 ()
BESP845L

  • Ex vivo cell culture medium

DMEM/F12 Baxter Special 9, 1000L - 05407010126600

No Description
Lonza Verviers
BESP845K
In Commercial Distribution

  • 05407010126600 ()
BESP845K

  • Ex vivo cell culture medium

Syva® RapidTest d.a.u.® 9 - 00842768001338

Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

VM AIR PI _ _ 9/16 G - 08592346893450

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729119US
Not in Commercial Distribution

  • 08592346893450 ()


  • Non-fixed medical gas cylinder regulator

MFU25 _AIR CH _ 9/16 G - 08592346892859

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728119US
In Commercial Distribution

  • 08592346892859 ()


  • Non-fixed medical gas cylinder regulator

MFU15 _AIR CH _ 9/16 G - 08592346892842

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728118US
In Commercial Distribution

  • 08592346892842 ()


  • Non-fixed medical gas cylinder regulator

MFU25 _AIR OH _ 9/16 G - 08592346892835

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728117US
In Commercial Distribution

  • 08592346892835 ()


  • Non-fixed medical gas cylinder regulator

MFU25 _ O2 CH _ 9/16 G - 08592346892798

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728114US
In Commercial Distribution

  • 08592346892798 ()


  • Non-fixed medical gas cylinder regulator

MFU15 _ O2 OH _ 9/16 G - 08592346892750

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728110US
In Commercial Distribution

  • 08592346892750 ()


  • Non-fixed medical gas cylinder regulator

MFU15 _ O2 DS _ 9/16 G - 08592346892736

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728108US
In Commercial Distribution

  • 08592346892736 ()


  • Non-fixed medical gas cylinder regulator

MFU2 _ O2 DS _ 9/16 G - 08592346892729

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728107US
In Commercial Distribution

  • 08592346892729 ()


  • Non-fixed medical gas cylinder regulator

MM60 _O2 DS _ 9/16UNF S - 08592346849570

Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
GCE, s.r.o.
0730114US
In Commercial Distribution

  • 08592346849570 ()


  • Medical gas flowmeter, Thorpe tube

MM30 _O2 DS _ 9/16UNF S - 08592346849563

Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
GCE, s.r.o.
0730113US
In Commercial Distribution

  • 08592346849563 ()


  • Medical gas flowmeter, Thorpe tube

VM O2 CGA870 _ _ 9/16 S - 08592346828087

The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729108US
Not in Commercial Distribution

  • 08592346828087 ()


  • Non-fixed medical gas cylinder regulator
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