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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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Arthrex® - 00888867284227

PASSPORT BUTTON CANNULA
ARTHREX, INC.
AR-6592-08-40-1
In Commercial Distribution

  • 00888867284227 ()
AR-6592-08-40-1

  • Bone access cannula

Arthrex® - 00888867283985

MULTIFIRE SCORPION NEEDLE
ARTHREX, INC.
AR-13995N-1
In Commercial Distribution

  • 00888867283985 ()
AR-13995N-1

  • Suturing unit, single-use

Arthrex® - 00888867283978

SUREFIRE SCORPION NEEDLE
ARTHREX, INC.
AR-13991N-1
In Commercial Distribution

  • 00888867283978 ()
AR-13991N-1

  • Suturing unit, single-use

Arthrex® - 00888867283961

SCORPION NEEDLE
ARTHREX, INC.
AR-13990N-1
In Commercial Distribution

  • 00888867283961 ()
AR-13990N-1

  • Suturing unit, single-use

Arthrex® - 00888867283329

FiberTape Cerclage Instrument Tray
ARTHREX, INC.
AR-7800C
In Commercial Distribution

  • 00888867283329 ()
AR-7800C

  • Surgical instrument/implant rack

Arthrex® - 00888867282339

DISP INSTRS KIT FOR MINI S-TAK
ARTHREX, INC.
AR-1322DSC-1
In Commercial Distribution

  • 00888867282339 ()
AR-1322DSC-1

  • Arthroscopic surgical procedure kit, non-medicated, single-use

Arthrex® - 00888867280847

Compression Screw Caddy 5.0mm
ARTHREX, INC.
AR-8750C-SC-02
In Commercial Distribution

  • 00888867280847 ()
AR-8750C-SC-02

  • Surgical instrument/implant rack

Arthrex® - 00888867280830

Compression Screw Caddy 7.0mm
ARTHREX, INC.
AR-8750C-SC-01
In Commercial Distribution

  • 00888867280830 ()
AR-8750C-SC-01

  • Surgical instrument/implant rack

Arthrex® - 00888867280823

5.0/7.0 Compression FT Instr. Case
ARTHREX, INC.
AR-8750C
In Commercial Distribution

  • 00888867280823 ()
AR-8750C

  • Surgical instrument/implant rack

Arthrex® - 00888867280724

Reamer Guide Pin, Sz 5 Mod (+2 mm Right)
ARTHREX, INC.
AR-9510RG-5R
In Commercial Distribution

  • 00888867280724 ()
AR-9510RG-5R

  • Orthopaedic reamer guide

Arthrex® - 00888867280717

Reamer Guide Pin, Sz 5 Mod (+2 mm Left)
ARTHREX, INC.
AR-9510RG-5L
In Commercial Distribution

  • 00888867280717 ()
AR-9510RG-5L

  • Orthopaedic reamer guide

Arthrex® - 00888867280700

Reamer Guide Pin, Sz 5 Mod (Neutral)
ARTHREX, INC.
AR-9510RG-5C
In Commercial Distribution

  • 00888867280700 ()
AR-9510RG-5C

  • Orthopaedic reamer guide

Arthrex® - 00888867279575

Caddy, 3.0mm Hybrid Screw Module
ARTHREX, INC.
AR-8933H-SC
In Commercial Distribution

  • 00888867279575 ()
AR-8933H-SC

  • Device sterilization/disinfection container, reusable

Surgical Direct - B382SD917665010

Alan-Parks Rectal Retractor, Complete Set, Blades 80mm & 95mm
Surgical Direct, Inc.
SD91766501
In Commercial Distribution

  • B382SD917665010 ()
SD91766501

  • Rectal speculum

Surgical Direct - B382SD9176610000

8 inch Barr Anal retractor
Surgical Direct, Inc.
SD917661000
In Commercial Distribution

  • B382SD9176610000 ()
SD917661000

  • Rectal speculum

Surgical Direct - B382SD917660150

6 inch Smith-Buie Anal Retractor
Surgical Direct, Inc.
SD91766015
In Commercial Distribution

  • B382SD917660150 ()
SD91766015

  • Rectal speculum

Surgical Direct - B382SD917640210

8 1/2 inch Pratt Rectal Speculum, 3 1/2 inch x 1 inch
Surgical Direct, Inc.
SD91764021
In Commercial Distribution

  • B382SD917640210 ()
SD91764021

  • Rectal speculum

Surgical Direct - B382SD917630150

8 3/4 inch Schulze Bergmann Rectal Specula, 150 mm
Surgical Direct, Inc.
SD91763015
In Commercial Distribution

  • B382SD917630150 ()
SD91763015

  • Rectal speculum

Surgical Direct - B382SD917630120

8 3/4 inch Schulze Bergmann Rectal Specula, 125 mm
Surgical Direct, Inc.
SD91763012
In Commercial Distribution

  • B382SD917630120 ()
SD91763012

  • Rectal speculum

Surgical Direct - B382SD917624150

6" Sims Rectal Specula, Fenestrated, Straight
Surgical Direct, Inc.
SD91762415
In Commercial Distribution

  • B382SD917624150 ()
SD91762415

  • Rectal speculum

Surgical Direct - B382SD917622190

9 3/4" Sims Rectal Specula, 80mm x 25mm
Surgical Direct, Inc.
SD91762219
In Commercial Distribution

  • B382SD917622190 ()
SD91762219

  • Rectal speculum

Surgical Direct - B382SD917622170

8 3/4" Sims Rectal Specula, 150mm x 20mm
Surgical Direct, Inc.
SD91762217
In Commercial Distribution

  • B382SD917622170 ()
SD91762217

  • Rectal speculum

Surgical Direct - B382SD9176201050

3 1/8 inch x 1 7/16 inch Hill-Ferguson Rectal Retractor
Surgical Direct, Inc.
SD917620105
In Commercial Distribution

  • B382SD9176201050 ()
SD917620105

  • Rectal speculum

Surgical Direct - B382SD9176201030

2 1/5 inch x 15/16 inch Hill-Ferguson Rectal Retractor
Surgical Direct, Inc.
SD917620103
In Commercial Distribution

  • B382SD9176201030 ()
SD917620103

  • Rectal speculum

Surgical Direct - B382SD917618220

8 3/4 inch Czerny Rectal Specula
Surgical Direct, Inc.
SD91761822
In Commercial Distribution

  • B382SD917618220 ()
SD91761822

  • Rectal speculum

Surgical Direct - B382SD9176911030

2" Fansler Proctoscope, Slotted Tube, 1" Diameter
Surgical Direct, Inc.
SD917691103
In Commercial Distribution

  • B382SD9176911030 ()
SD917691103

  • Rectal speculum

Surgical Direct - B382SD9176911020

6 7/8 Inch Chelsea Eaton Anal Speculum, Small, 7/8 Inch Diameter
Surgical Direct, Inc.
SD917691102
In Commercial Distribution

  • B382SD9176911020 ()
SD917691102

  • Rectal speculum

Surgical Direct - B382SD9176911010

2 3/8” Fansler Proctoscope, Slotted Tube, 1 1/3” Diameter
Surgical Direct, Inc.
SD917691101
In Commercial Distribution

  • B382SD9176911010 ()
SD917691101

  • Rectal speculum

Surgical Direct - B382SD9176911000

Chelsea Eaton Anal Speculum, Large, 1 1/4 inch Diameter
Surgical Direct, Inc.
SD917691100
In Commercial Distribution

  • B382SD9176911000 ()
SD917691100

  • Rectal speculum

Surgical Direct - B382SD917672000

3 3/8 inch Pennington Rectal Speculum, 1 inch Diameter, 4 1/2 inch Long Handle, With Obturator
Surgical Direct, Inc.
SD91767200
In Commercial Distribution

  • B382SD917672000 ()
SD91767200

  • Rectal speculum

Surgical Direct - B382SD917671040

Hirschmann Anoscope, with Obturator 22mm x 125mm
Surgical Direct, Inc.
SD91767104
In Commercial Distribution

  • B382SD917671040 ()
SD91767104

  • Rectal speculum

Surgical Direct - B382SD917671030

Hirschmann Anoscope, 24mm x 90mm
Surgical Direct, Inc.
SD91767103
In Commercial Distribution

  • B382SD917671030 ()
SD91767103

  • Rectal speculum

Surgical Direct - B382SD9176701100

2 3/4" Hirschmann Rectal Speculum, Medium, 11/16" Diameter
Surgical Direct, Inc.
SD917670110
In Commercial Distribution

  • B382SD9176701100 ()
SD917670110

  • Rectal speculum

Surgical Direct - B382SD917670100

3 1/2" Hirschman Anoscope Large
Surgical Direct, Inc.
SD91767010
In Commercial Distribution

  • B382SD917670100 ()
SD91767010

  • Rectal speculum

Surgical Direct - B382SD917670030

Hirschmann Proctoscope, 22mm x 65mm
Surgical Direct, Inc.
SD91767003
In Commercial Distribution

  • B382SD917670030 ()
SD91767003

  • Rectal speculum

Surgical Direct - B382SD917670020

19mm x 65mm Hirschman Anoscope
Surgical Direct, Inc.
SD91767002
In Commercial Distribution

  • B382SD917670020 ()
SD91767002

  • Rectal speculum

Surgical Direct - B382SD917670010

16mm x 65mm Hirschmann Proctoscope
Surgical Direct, Inc.
SD91767001
In Commercial Distribution

  • B382SD917670010 ()
SD91767001

  • Rectal speculum

Surgical Direct - B382SD917668220

22mm Ives-Fansler Retractor
Surgical Direct, Inc.
SD91766822
In Commercial Distribution

  • B382SD917668220 ()
SD91766822

  • Rectal speculum

Surgical Direct - B382SD9176681000

3 3/8 inch Ives-Fansler Anoscope With Plastic Obturator 1 inch Diameter.
Surgical Direct, Inc.
SD917668100
In Commercial Distribution

  • B382SD9176681000 ()
SD917668100

  • Rectal speculum

Surgical Direct - B382SD917622150

6 inch Sims Rectal Speculum
Surgical Direct, Inc.
SD91762215
In Commercial Distribution

  • B382SD917622150 ()
SD91762215

  • Rectal speculum

Surgical Direct - B382SD9176201060

Extra Large Hill-Ferguson Rectal Retractor 1 1/2 inch Blade
Surgical Direct, Inc.
SD917620106
In Commercial Distribution

  • B382SD9176201060 ()
SD917620106

  • Rectal speculum

Surgical Direct - B382SD9176201040

3 Inch x 1 3/8 Inch Hill-Ferguson Rectal Retractor
Surgical Direct, Inc.
SD917620104
In Commercial Distribution

  • B382SD9176201040 ()
SD917620104

  • Rectal speculum

Surgical Direct - B382SD9176201000

3 inch x 1 3/16 inch Hill-Ferguson Rectal Retractor
Surgical Direct, Inc.
SD917620100
In Commercial Distribution

  • B382SD9176201000 ()
SD917620100

  • Rectal speculum

Surgical Direct - B382SD917619030

Sawyer Retractor, 89 x 38mm
Surgical Direct, Inc.
SD91761903
In Commercial Distribution

  • B382SD917619030 ()
SD91761903

  • Rectal speculum

Surgical Direct - B382SD917619020

Sawyer Retractor, 76 x 28mm
Surgical Direct, Inc.
SD91761902
In Commercial Distribution

  • B382SD917619020 ()
SD91761902

  • Rectal speculum

Surgical Direct - B382SD917619010

Sawyer Retractor, 64 x 22mm
Surgical Direct, Inc.
SD91761901
In Commercial Distribution

  • B382SD917619010 ()
SD91761901

  • Rectal speculum

Surgical Direct - B382SD9176180010

2 1/2" Chelsea Eaton Anal Speculum, Small, 7/8" Diameter
Surgical Direct, Inc.
SD917618001
In Commercial Distribution

  • B382SD9176180010 ()
SD917618001

  • Rectal speculum

Integra® Miltex® - 10381780415145

Integra® Miltex® Tissue Nipper, 5", Convex Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
V940251
In Commercial Distribution

  • H834V9402510 ()
  • 10381780415145 ()
V940251

  • Nail clippers, reusable

Integra® Miltex® - 10381780415084

Integra® Miltex® Tissue Nipper, 4", Straight Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
V940220
In Commercial Distribution

  • H834V9402200 ()
  • 10381780415084 ()
V940220

  • Nail clippers, reusable

Integra® Miltex® - 10381780415060

Integra® Miltex® Nail Nipper, 5-5/8", Straight Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
V940212
In Commercial Distribution

  • H834V9402120 ()
  • 10381780415060 ()
V940212

  • Nail clippers, reusable
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