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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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External Fixator Reduction sleeve 15/9 - 07640136270040

Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1026
In Commercial Distribution

  • 07640136270040 ()


  • External orthopaedic fixation system, single-use

MedGyn Pessary Oval w/support # 9 - M803050119

Oval Pessary is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Oval w/support # 9
In Commercial Distribution

  • M803050119 ()
050119

  • Pelvic-organ-supporting pessary

MedGyn Pessary Cube w/drain # 9 - M803050075

Cube Pessary is used treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Cube w/drain # 9
In Commercial Distribution

  • M803050075 ()
050075

  • Pelvic-organ-supporting pessary

MedGyn Pessary Ring w/support #9 - M803050034

Pessary ring is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Ring w/support #9
In Commercial Distribution

  • M803050034 ()
050034

  • Pelvic-organ-supporting pessary

3-lumen UPP Pressure Catheter 9 Fr. - 10627825007105

No Description
Laborie Medical Technologies Canada ULC
9021P5091
In Commercial Distribution

  • 20627825007102 ()
  • 10627825007105 ()
  • 30627825007109 ()


  • Urodynamic manometric catheter, non-electronic

SITTER 3.5mm Versatile Plate, 9 Hole - 07640187462173

No Description
Bonebridge AG
B-240100
In Commercial Distribution

  • 07640187462173 ()


  • Orthopaedic fixation plate, non-bioabsorbable

Racord Plus Retraction Cord 9/1 - 00310866002422

Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
In Commercial Distribution

  • 00310866002422 ()
07810

  • Gingival retraction cord, medicated

Racord Two Retraction Cord 9/1 - 00310866000589

Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
Not in Commercial Distribution

  • 00310866000589 ()
07810

  • Gingival retraction cord, medicated

SilTrax Plain Retraction Cord 9/1 - 00310866000466

Untreated Braided Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07410
In Commercial Distribution

  • 00310866000466 ()
07410

  • Gingival retraction cord, non-medicated

SilTrax Plus Retraction Cord 9/1 - 00310866000428

Braided Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size:9/1,
PASCAL COMPANY, INC.
07310
In Commercial Distribution

  • 00310866000428 ()
07310

  • Gingival retraction cord, medicated

SilTrax EPI Retraction Cord 9/1 - 00310866000381

Braided gingival retraction cord with epinephrine, 72 inches, size 9/1
PASCAL COMPANY, INC.
07210
In Commercial Distribution

  • 00310866000381 ()
07210

  • Gingival retraction cord, medicated

SilTrax AS Retraction Cord 9/1 - 00310866000343

Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07110
In Commercial Distribution

  • 00310866000343 ()
07110

  • Gingival retraction cord, non-medicated

Titanium 3D rib clip, 9 segments - 04260029580921

No Description
MedXpert GmbH
014-01009
In Commercial Distribution

  • 04260029580921 ()
014-01009

  • Rib/rib cage internal fixation/bracing system fixation grip/anchor

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

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

9" ABDOMINAL BINDER UP TO 45" - 00610570107261

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

  • 00610570107261 ()


  • Abdominal binder, single-use

Distal Reduces Aria Broach Size 9 - 09348215073435

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

  • 09348215073435 ()


  • Orthopaedic broach

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

SUCTION TIP BARBEE, 9 IN. LENGTH - D9281061020

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

  • D9281061020 ()


  • Dental suction system cannula, reusable

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

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 CH S/E - D9281051999SECH0

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

  • D9281051999SECH0 ()


  • Dental osteotome set

SINUS INSTRUMENT #9 HD D/E - D9281051999HD0

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

  • D9281051999HD0 ()


  • 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

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

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

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

No Description
Dynarex Corporation
4621
In Commercial Distribution

  • 00616784462134 ()
  • 00616784462110 ()


  • Tracheostomy tube neck holder, reusable

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

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

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

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

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

  • 00848665001877 ()


  • Surgical screwdriver, reusable

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

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

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

EUROLINE ENA Profile 9 Ag (IgG) - 04049016124900

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-1601-9 G
In Commercial Distribution

  • 04049016124900 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

EUROLINE ENA Profile 9 Ag (IgG) - 04049016124917

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-6401-9 G
In Commercial Distribution

  • 04049016124917 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

EEG Leads, 0.6m, reusable, 9 pcs - 04049098008013

No Description
DRAEGER MEDICAL SYSTEMS, INC.
5947804
In Commercial Distribution

  • 04049098008013 ()
  • 04049098058223 ()


  • Electrocardiographic lead set, reusable

Prettau® Zirconia 9 (2 pieces) - D800ZRAD0502

Content: 2 pieces Height: 16 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0502
In Commercial Distribution

  • D800ZRAD0502 ()


  • Dental bridge, ceramic

Zirconia Translucent 9 High (2 pieces) - D800ZRAB5501

Content: 2 pieces Height: 22 mm Translucent zirconia for single crowns to large bridges (reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAB5501
In Commercial Distribution

  • D800ZRAB5501 ()


  • Dental bridge, ceramic

9 x 33mm Citrelock ACL Implant - 00810027270634

No Description
Acuitive Technologies, Inc.
30-103-0933
In Commercial Distribution

  • 00810027270634 ()
30-103-0933

  • Tendon/ligament bone anchor, bioabsorbable
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