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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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Quadra P femoral stems - 07630971243613

Quadra-P Short Neck LAT stem #9
Medacta International SA
01.12.279
In Commercial Distribution

  • 07630971243613 ()


  • Press-fit hip femur prosthesis, one-piece

REFORM - 00815362024034

REFORM LATERAL OFFSET 20mm (qty 9)
PRECISION SPINE, INC.
00819RM
In Commercial Distribution

  • 00815362024034 ()
39-LO-0220

  • Bone-screw internal spinal fixation system connector

SURE LOK (TM) - 00815362022849

MD MAXTRIPLE LEAD 5.5x55MM (QTY 9)
PRECISION SPINE, INC.
7406PS
In Commercial Distribution

  • 00815362022849 ()
43-TL-5555

  • Spinal bone screw, non-bioabsorbable

BOSS Instruments - 00888515224377

Pterygo-Masseteric Sling Stripper, Lt, 6.5mm, 9"
BOSS INSTRUMENTS, LTD., INC.
85-0588
In Commercial Distribution

  • 00888515224377 ()
85-0588

  • Periosteal elevator, reusable

BOSS Instruments - 00888515224353

Pterygo-Masseteric Sling Stripper, Rt, 6.5mm, 9"
BOSS INSTRUMENTS, LTD., INC.
85-0584
In Commercial Distribution

  • 00888515224353 ()
85-0584

  • Periosteal elevator, reusable

BOSS Instruments - 00888515223608

Obwegeser Zygomatic Arch Awl, cvd, 9"
BOSS INSTRUMENTS, LTD., INC.
85-0150
In Commercial Distribution

  • 00888515223608 ()
85-0150

  • Bone awl, reusable

BOSS Instruments - 00888515223493

Pterygo Maxillary Osteo, 9 1/4"
BOSS INSTRUMENTS, LTD., INC.
85-0130
In Commercial Distribution

  • 00888515223493 ()
85-0130

  • Plastic surgery osteotome

BOSS Instruments - 00888515204607

Wire Passer Cannulated, 70mm dia, 9"
BOSS INSTRUMENTS, LTD., INC.
79-0332
In Commercial Distribution

  • 00888515204607 ()
79-0332

  • Wire/ligature passer, reusable

BOSS Instruments - 00888515199842

Hohmann Retr, 18mm blade width, 9"
BOSS INSTRUMENTS, LTD., INC.
77-0618
In Commercial Distribution

  • 00888515199842 ()
77-0618

  • Hand-held surgical retractor, reusable

BOSS Instruments - 00888515199835

Hohmann Retr, 10mm blade width, 9"
BOSS INSTRUMENTS, LTD., INC.
77-0610
In Commercial Distribution

  • 00888515199835 ()
77-0610

  • Hand-held surgical retractor, reusable

BOSS Instruments - 00888515198869

Chandler Elev, 17 x 25mm, 9"
BOSS INSTRUMENTS, LTD., INC.
77-0384
In Commercial Distribution

  • 00888515198869 ()
77-0384

  • Periosteal elevator, reusable

BOSS Instruments - 00888515196063

Multi Hole Suct Tube, 9", 5fr
BOSS INSTRUMENTS, LTD., INC.
74-5276
In Commercial Distribution

  • 00888515196063 ()
74-5276

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

BOSS Instruments - 00888515192812

Adson Aneurysm Needle, 9" hollow handle
BOSS INSTRUMENTS, LTD., INC.
74-0334
In Commercial Distribution

  • 00888515192812 ()
74-0334

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

BOSS Instruments - 00888515187849

Murphy Ball Hook, 9" 2.3mm ball
BOSS INSTRUMENTS, LTD., INC.
73-5032
In Commercial Distribution

  • 00888515187849 ()
73-5032

  • Soft-tissue surgical hook, reusable

BOSS Instruments - 00888515187764

Cushing Gasserian Ganglion Hook, blunt, 9"
BOSS INSTRUMENTS, LTD., INC.
73-5017
In Commercial Distribution

  • 00888515187764 ()
73-5017

  • Nerve/vessel retractor

BOSS Instruments - 00888515182431

Ball Probe, 4mm, 9 1/2"
BOSS INSTRUMENTS, LTD., INC.
73-1590
In Commercial Distribution

  • 00888515182431 ()
73-1590

  • Open-surgery dissector

Surgical Direct - B382SD1455630000

9" Mallet, 1lb 11oz, Phenolic Handle
Surgical Direct, Inc.
SD14556-3000
In Commercial Distribution

  • B382SD1455630000 ()
SD14556-3000

  • Surgical mallet

Surgical Direct - B382SD1426525000

9 1/2" Large Locking Pliers
Surgical Direct, Inc.
SD14265-2500
In Commercial Distribution

  • B382SD1426525000 ()
SD14265-2500

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SDM435080

9 inch Bruns Curette, Size 5
Surgical Direct, Inc.
SDM43508
In Commercial Distribution

  • B382SDM435080 ()
SDM43508

  • Bone curette, reusable

Surgical Direct - B382SDM435060

9 inch Bruns Curette, Size 3
Surgical Direct, Inc.
SDM43506
In Commercial Distribution

  • B382SDM435060 ()
SDM43506

  • Bone curette, reusable

Surgical Direct - B382SDM435040

9 inch Bruns Curette, Size 1
Surgical Direct, Inc.
SDM43504
In Commercial Distribution

  • B382SDM435040 ()
SDM43504

  • Bone curette, reusable

Surgical Direct - B382SD929314100

Dental Explorer Figure 9, Round Handle
Surgical Direct, Inc.
SD92931410
In Commercial Distribution

  • B382SD929314100 ()
SD92931410

  • Dental elevator, tooth/root

Surgical Direct - B382SD922615230

9 inch Dandy Nerve Hook, Straight
Surgical Direct, Inc.
SD92261523
In Commercial Distribution

  • B382SD922615230 ()
SD92261523

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382SD922609410

9" Scoville Nerve Hook, 8mm Straight
Surgical Direct, Inc.
SD92260941
In Commercial Distribution

  • B382SD922609410 ()
SD92260941

  • Bone lever/elevator, reusable

Spine Instruments - 07630040792493

Shaver with double blade 9 mm
Medacta International SA
03.22.10.1213
In Commercial Distribution

  • 07630040792493 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Surgical Direct - B382SD99238561000

Schluger Periodontal File, Fig. 9/10
Surgical Direct, Inc.
SD9923856100
In Commercial Distribution

  • B382SD99238561000 ()
SD9923856100

  • Callous file/rasp, reusable

iSmile - 00816419020375

Sterilization Pouch 3-1/2" x 9"
Ismile Dental Products, Inc.
45-2505
In Commercial Distribution

  • 20816419020379 ()
  • 00816419020375 ()
45-2505

  • Sterilization packaging, single-use

iSmile - 00816419020351

Sterilization Pouch 2-3/4" x 9"
Ismile Dental Products, Inc.
45-2503
In Commercial Distribution

  • 20816419020355 ()
  • 00816419020351 ()
45-2503

  • Sterilization packaging, single-use

Surgical Direct - B382SD9194463170

9 inch Jako-Kleinsasser Micro Scissors, Straight
Surgical Direct, Inc.
SD919446317
In Commercial Distribution

  • B382SD9194463170 ()
SD919446317

  • Laryngoscope handle, reusable

Surgical Direct - B382SD919443250

9" Kleinsasser Micro Scissors, Curved Right
Surgical Direct, Inc.
SD91944325
In Commercial Distribution

  • B382SD919443250 ()
SD91944325

  • Laryngoscope handle, reusable

Surgical Direct - B382SD919443240

9" Kleinsasser Micro Scissors, Curved Left
Surgical Direct, Inc.
SD91944324
In Commercial Distribution

  • B382SD919443240 ()
SD91944324

  • Laryngoscope handle, reusable

Surgical Direct - B382SD918710300

9 Inch Debakey Coarctation 5.5cm Jaw
Surgical Direct, Inc.
SD91871030
In Commercial Distribution

  • B382SD918710300 ()
SD91871030

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD9187101200

9 inch Overstreet Endometrial Polyp Forceps
Surgical Direct, Inc.
SD918710120
In Commercial Distribution

  • B382SD9187101200 ()
SD918710120

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD9187091000

9 7/8" Harken Auricle Clamp
Surgical Direct, Inc.
SD918709100
In Commercial Distribution

  • B382SD9187091000 ()
SD918709100

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD918650050

9" Debakey-Bahnson Aorta Clamp, Acutely Curved
Surgical Direct, Inc.
SD91865005
In Commercial Distribution

  • B382SD918650050 ()
SD91865005

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD918583200

9 inch Debakey Peripheral Vascular Clamp
Surgical Direct, Inc.
SD91858320
In Commercial Distribution

  • B382SD918583200 ()
SD91858320

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD918491230

9 inch De Bakey Forcep, Curved
Surgical Direct, Inc.
SD91849123
In Commercial Distribution

  • B382SD918491230 ()
SD91849123

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD918487230

9 inch Debakey Atrauma Forcep, Angled
Surgical Direct, Inc.
SD91848723
In Commercial Distribution

  • B382SD918487230 ()
SD91848723

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD917211230

9 inch Mayo-Robson Intestinal Forceps, Curved
Surgical Direct, Inc.
SD91721123
In Commercial Distribution

  • B382SD917211230 ()
SD91721123

  • Dressing/utility forceps, scissors-like, reusable

iNSitu™ Hip System - 00816127026737

Shortened Dual Taper Broach, Size 9
NEXTSTEP ARTHROPEDIX, LLC
10-80-0609
In Commercial Distribution

  • 00816127026737 ()


  • Orthopaedic broach

TheRay Collared and Collarless Femoral Stem - 00816127026591

Femoral Broach, Collared Stem, Size 9
NEXTSTEP ARTHROPEDIX, LLC
12-80-0009
In Commercial Distribution

  • 00816127026591 ()


  • Orthopaedic broach

iNSitu™ Hip System - 00816127025181

Medial/Lateral Compaction Broach, Size 9
NEXTSTEP ARTHROPEDIX, LLC
10-80-0509
In Commercial Distribution

  • 00816127025181 ()


  • Orthopaedic broach

iNSitu Total Hip System - 00816127024870

Cemented Femoral Stem, Size 9, Lateralized
NEXTSTEP ARTHROPEDIX, LLC
10-16-0009
In Commercial Distribution

  • 00816127024870 ()


  • Uncoated hip femur prosthesis, modular

iNSitu Total Hip System - 00816127024726

Cemented Femoral Stem, Size 9, Standard
NEXTSTEP ARTHROPEDIX, LLC
10-15-0009
In Commercial Distribution

  • 00816127024726 ()


  • Uncoated hip femur prosthesis, modular

Arthrex® - 00888867137899

UNIVERS APEX HUMERAL BROACH, SIZE 9
ARTHREX, INC.
AR-9231-09S
In Commercial Distribution

  • 00888867137899 ()
AR-9231-09S

  • Bone file/rasp, manual, reusable

Arthrex® - 00888867136946

UNIVERS APEX PROTECTOR POST, SIZE 9
ARTHREX, INC.
AR-9200-19S
In Commercial Distribution

  • 00888867136946 ()
AR-9200-19S

  • Surgical implant/trial-implant/sizer holder, reusable

Surgical Direct - B382SD903971230

9 inch Metzenbaum Scissor, Curved, TC
Surgical Direct, Inc.
SD90397123
In Commercial Distribution

  • B382SD903971230 ()
SD90397123

  • General-purpose surgical scissors, single-use

Surgical Direct - B382SD903971130

9 inch Metzenbaum Scissors, Curved, Delicate
Surgical Direct, Inc.
SD90397113
In Commercial Distribution

  • B382SD903971130 ()
SD90397113

  • General-purpose surgical scissors, single-use

Surgical Direct - B382SD903970230

9 inch Metzenbaum Scissors, Straight, Delicate
Surgical Direct, Inc.
SD90397023
In Commercial Distribution

  • B382SD903970230 ()
SD90397023

  • General-purpose surgical scissors, single-use

Surgical Direct - B382SD903941230

9 inch Metzenbaum Scissor, Curved, TC
Surgical Direct, Inc.
SD90394123
In Commercial Distribution

  • B382SD903941230 ()
SD90394123

  • General-purpose surgical scissors, single-use
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