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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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Boule Con-Diff Tri-Level - 00812137010230

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution

  • 00812137010230 ()
  • 00812137011800 ()
501-607

  • Full blood count IVD, control

UNBRANDED - 00887661217653

No Description
FGX INTERNATIONAL INC.
DL4033/9.FTG
In Commercial Distribution

  • 00887661217653 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00887661635082

No Description
FGX INTERNATIONAL INC.
DL4719/9.FTG
In Commercial Distribution

  • 00887661635082 ()


  • Tinted non-prescription spectacles

CarboClear Lumbar Cage System - 07290110206437

A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, the Shaver width also enables estimation of the intervertebral space height.
CARBOFIX ORTHOPEDICS LTD
Shaver – 9 mm
In Commercial Distribution

  • 07290110206437 ()
CCLC9009

  • Bone curette, reusable

N/A - ENTTTA9S3D3745

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
TA 9.S33D3.745
In Commercial Distribution

  • ENTTTA9S3D3745 ()

  • Outer Diameter: 3.7 Millimeter
  • Outer Diameter: 4.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Outer Diameter: 5.0 Millimeter
  • Outer Diameter: 6.0 Millimeter
  • Outer Diameter: 7.0 Millimeter
  • Outer Diameter: 8.0 Millimeter


  • Dental implant abutment analog, intraoral-scanning, single-use

MulTipeg™ - 07350096321194

No Description
Integration Diagnostics Sweden AB
MulTipeg™ 9
In Commercial Distribution

  • 07350096321194 ()
55019

  • Multimeter

Avaline Medical NJ LLC - 00810124536282

Paper Surgical Tape with Dispenser 1"x10 Yards
Avaline Medical NJ Limited Liability Company
1in+DIP +9
In Commercial Distribution

  • 00810124536329 ()
  • 00810124536282 ()


  • Multi-purpose surgical skin adhesive tape

Avaline Medical NJ LLC - 00810124535933

Paper Surgical Tape with Dispenser 2"x10 Yards
Avaline Medical NJ Limited Liability Company
2in+DIP +9
In Commercial Distribution

  • 00810124536336 ()
  • 00810124535933 ()


  • Multi-purpose surgical skin adhesive tape

CONMED - 10845854041666

HIGH STRENGTH BREAKAWAY GUIDE PIN, 9 IN, STERILE, 2.4 X 229 MM (.093 X 9 IN)
Conmed Corporation
9743D
In Commercial Distribution

  • 20845854041663 ()
  • 10845854041666 ()
  • 00845854041669 ()
9743D

  • Orthopaedic guidewire, single-use

ProCure - 10840330702987

ProCure - Soft Silicone Foam Dressing w/Border Sacral Large 9"x 9" - 5ea/bx 40bx/cs
Twin Med, LLC
PCHF3311
In Commercial Distribution

  • 30840330702981 ()
  • 10840330702987 ()
  • 50840330702985 ()

  • Width: 9 Inch
  • Length: 9 Inch
PCHF3311

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Mini Master Series - 00190746108129

DB BKT MINI MS UL LAT 022 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1074B
In Commercial Distribution

  • 00190746108129 ()
390-1074B

  • Orthodontic bracket, metal

Mini Master Series - 00190746108105

DB BKT MINI MS UL LAT 018 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1064B
In Commercial Distribution

  • 00190746108105 ()
390-1064B

  • Orthodontic bracket, metal

Mini Master Series - 00190746108082

DB BKT MINI MS UR LAT 022 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1073B
In Commercial Distribution

  • 00190746108082 ()
390-1073B

  • Orthodontic bracket, metal

Mini Master Series - 00190746108068

DB BKT MINI MS UR LAT 018 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1063B
In Commercial Distribution

  • 00190746108068 ()
390-1063B

  • Orthodontic bracket, metal

AESCULAP - 04038653175345

DESMARRES Lid Retractor, 5 1/2", (140 mm), depth: 9 mm, width: 9 mm, non-sterile, reusable
Aesculap AG
OA310R
In Commercial Distribution

  • 04038653175345 ()
OA310R

  • Nerve/vessel retractor

Hayden Medical - 00840319743256

Hurd Tonsil Dissector and Pillar Retractor 9" (22.5cm), standard pattern, 9 x 25mm blade, 13mm retractor
Hayden Medical, Inc.
202-854
In Commercial Distribution

  • 00840319743256 ()
202-854

  • Hand-held surgical retractor, reusable

JAGUAR LUMBAR I/F CAGE - 10705034186849

JAGUAR LUMBAR I/F CAGE SYSTEM WEDGED TRIAL SPACER 9 x (9 x 13) x 25mm
DEPUY SPINE, LLC
273125409
Not in Commercial Distribution

  • 10705034186849 ()
273125409

  • Spinal implant trial

Novo Surgical - G586N684024XL0

frazier suction tube, straight, 9 fr., working length 6 3/4" (17.1 cm), 9" (22.9 cm)
NOVO SURGICAL, INC.
N6840-24XL
In Commercial Distribution

  • G586N684024XL0 ()
N6840-24XL

  • Surgical/emergency suction cannula, non-illuminating, reusable

Symmetry Gillies - 00887482050590

Symmetry® Elevator, Gillies Zygoma, Angle To Tip 35 mm, 9 mm Tip Width, 9 in
SYMMETRY SURGICAL INC.
68-4510
In Commercial Distribution

  • 00887482050590 ()

  • Length: 9 Inch
  • Width: 9 Millimeter
68-4510

  • Bone lever/elevator, reusable

Symmetry Ferguson - 00887482174708

Symmetry® Scoop, Ferguson Gall Stone, Double-Ended, 9 mm & 11 mm, Small, 9 1/2 in
SYMMETRY SURGICAL INC.
51-1501
In Commercial Distribution

  • 00887482174708 ()

  • Length: 9.5 Inch
  • Circumference: 9 Millimeter
  • Circumference: 11 Millimeter
51-1501

  • Gallstone scoop

Surgical Direct - B382SD9026931010

7 1/2 Inch Cushing-Brown Bayonet Tissue Forcep, Double Row 9 x 9 Teeth, Scraper End
Surgical Direct, Inc.
SD902693101
In Commercial Distribution

  • B382SD9026931010 ()
SD902693101

  • Dressing/utility forceps, scissors-like, reusable

Simpex Steinmann Pin - B068T140S1

Smooth Steinmann Pin, Single Trocar Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
T-140-S
In Commercial Distribution

  • B068T140S1 ()

  • Outer Diameter: 3.6 Millimeter
  • Length: 229 Millimeter
T-140-S

  • Orthopaedic bone pin, non-bioabsorbable

Simpex Steinmann Pin - B068T1401

Smooth Steinmann Pin, Double Trocar Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
T-140
In Commercial Distribution

  • B068T1401 ()

  • Length: 229 Millimeter
  • Outer Diameter: 3.6 Millimeter
T-140

  • Orthopaedic bone pin, non-bioabsorbable

Simpex Steinmann Pin - B068D140S1

Smooth Steinmann Pin, Single Diamond Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
D-140-S
In Commercial Distribution

  • B068D140S1 ()

  • Length: 229 Millimeter
  • Outer Diameter: 3.6 Millimeter
D-140-S

  • Orthopaedic bone pin, non-bioabsorbable

Simpex Steinmann Pin - B068D1401

Smooth Steinmann Pin, Double Diamond Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
D-140
In Commercial Distribution

  • B068D1401 ()

  • Outer Diameter: 3.6 Millimeter
  • Length: 229 Millimeter
D-140

  • Orthopaedic bone pin, non-bioabsorbable

Symmetry Faulkner - 00887482118948

Symmetry® Curette, Faulkner Antrum, Double-Ended, 6 mm x 9 mm Rings, Malleable Shaft, 9 in
SYMMETRY SURGICAL INC.
63-7501
In Commercial Distribution

  • 00887482118948 ()

  • Width: 6 Millimeter
  • Depth: 9 Millimeter
  • Length: 9 Inch
63-7501

  • Bone curette, 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

Persona® - 00889024560475

No Description
Zimmer, Inc.
42-5891-007-20
In Commercial Distribution

  • 00889024560475 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / E, F
42-5891-007-20

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024560451

No Description
Zimmer, Inc.
42-5891-005-20
In Commercial Distribution

  • 00889024560451 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / C, D
42-5891-005-20

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024560499

No Description
Zimmer, Inc.
42-5891-009-20
In Commercial Distribution

  • 00889024560499 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / G, H
42-5891-009-20

  • Knee tibia prosthesis trial, reusable
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