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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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Ambler Surgical - 00190660213411

Masson-Luethy needle holder, 8'', bayonet shaft, TC jaws
AMBLER SURGICAL CORP.
Masson-Luethy needle holder
In Commercial Distribution

  • 00190660213411 ()
52-124

  • Suturing needle holder, reusable

Ambler Surgical - 00190660213404

Julian needle holder, 8 1/4'', straight, serrated TC jaws, gold ring handle, left handed
AMBLER SURGICAL CORP.
Julian needle holder
In Commercial Distribution

  • 00190660213404 ()
51-985-L

  • Suturing needle holder, reusable

Ambler Surgical - 00190660213398

Julian needle holder, 10 1/2'', curved, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Julian needle holder
In Commercial Distribution

  • 00190660213398 ()
52-005

  • Suturing needle holder, reusable

Ambler Surgical - 00190660213374

Heaney needle holder, 8 1/4'', curved, serrated TC jaws, gold ring handle, left handed
AMBLER SURGICAL CORP.
Heaney needle holder
In Commercial Distribution

  • 00190660213374 ()
51-703-L

  • Suturing needle holder, reusable

Ambler Surgical - 00190660213343

Julian needle holder, 11'', curved, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Julian needle holder
In Commercial Distribution

  • 00190660213343 ()
52-006

  • Suturing needle holder, reusable

Ambler Surgical - 00190660213336

Heaney needle holder, 6 1/4'', curved, serrated jaws, ring handle
AMBLER SURGICAL CORP.
Heaney needle holder
In Commercial Distribution

  • 00190660213336 ()
51-699

  • Suturing needle holder, reusable

Ambler Value Line - 00190660213329

Halsey needle holder, 5'', straight, smooth jaws, ring handle
AMBLER SURGICAL CORP.
Halsey needle holder
In Commercial Distribution

  • 00190660213329 ()
51-601

  • Suturing needle holder, reusable

Ambler Surgical - 00190660213312

Derf needle holder, 4 3/4'', straight, smooth TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Derf needle holder
In Commercial Distribution

  • 00190660213312 ()
51-104

  • Suturing needle holder, reusable

Ambler Value Line - 00190660213305

Cooley microvascular needle holder, 6 3/4'', delicate, straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Cooley microvascular needle holder
In Commercial Distribution

  • 00190660213305 ()
150-605

  • Suturing needle holder, reusable

restor3d Reusable Trial - 00840097502137

Reusable Trial, Cotton Wedge, Medium Footprint
Restor3d, Inc.
5000-0202
In Commercial Distribution

  • 00840097502137 ()


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

restor3d Reusable Trial - 00840097502120

Reusable Trial, Cotton Wedge, Small Footprint
Restor3d, Inc.
5000-0201
In Commercial Distribution

  • 00840097502120 ()


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

restor3d Reusable Trial - 00840097502113

Reusable Trial, Evans Wedge, Large Footprint
Restor3d, Inc.
5000-0303
In Commercial Distribution

  • 00840097502113 ()


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

restor3d Reusable Trial - 00840097502106

Reusable Trial, Evans Wedge, Medium Footprint
Restor3d, Inc.
5000-0302
In Commercial Distribution

  • 00840097502106 ()


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

restor3d Reusable Trial - 00840097502090

Reusable Trial, Evans Wedge, Small Footprint
Restor3d, Inc.
5000-0301
In Commercial Distribution

  • 00840097502090 ()


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

restor3d Reusable Inserter - 00840097502083

Reusable Inserter, Evans Wedge
Restor3d, Inc.
5000-0101
In Commercial Distribution

  • 00840097502083 ()


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

restor3d Reusable Instrument Tray - 00840097502076

Instrument Tray, Osteotomy Wedge System
Restor3d, Inc.
5000-0401
In Commercial Distribution

  • 00840097502076 ()


  • Device sterilization/disinfection container, reusable

restor3d Disposable Instrument, Wedge - 00840097501505

Disposable Inserter, Evans Wedge, Non-Sterile
Restor3d, Inc.
6101-INSERTER-NS
In Commercial Distribution

  • 00840097501505 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

restor3d Disposable Instrument, Wedge - 00840097501499

Disposable Inserter, Evans wedge
Restor3d, Inc.
6101-INSERTER
In Commercial Distribution

  • 00840097501499 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

restor3d Reusable Instrument Tray/Kit - 00840097501338

Reusable Instrument Tray/Kit, Osteotomy Wedge System
Restor3d, Inc.
5000-0401K
In Commercial Distribution

  • 00840097501338 ()


  • Device sterilization/disinfection container, reusable

INTERSEAL® - M6843000CI021

No Description
Microport Orthopedics Inc.
3000CI02
In Commercial Distribution

  • M6843000CI021 ()
3000CI02

  • Joint prosthesis implantation kit, reusable

INTERSEAL® - M6843000CI011

No Description
Microport Orthopedics Inc.
3000CI01
In Commercial Distribution

  • M6843000CI011 ()
3000CI01

  • Joint prosthesis implantation kit, reusable

NA - 03596010652508

RASP XL
Smith & Nephew, Inc.
72202629
In Commercial Distribution

  • 03596010652508 ()
72202629

  • Bone file/rasp, manual, reusable

NA - 03596010651433

ARTHRO-ROUND XL
Smith & Nephew, Inc.
72202586
In Commercial Distribution

  • 03596010651433 ()
72202586

  • Rigid endoscopic grasping forceps, reusable

NA - 03596010651426

ELEVATOR XL
Smith & Nephew, Inc.
72202628
In Commercial Distribution

  • 03596010651426 ()
72202628

  • Bone lever/elevator, reusable

PATH® - M684200700161

No Description
Microport Orthopedics Inc.
20070016
In Commercial Distribution

  • M684200700161 ()
20070016

  • Joint prosthesis implantation kit, reusable

LOW - M684200100111

No Description
Microport Orthopedics Inc.
20010011
In Commercial Distribution

  • M684200100111 ()
20010011

  • Joint prosthesis implantation kit, reusable

Ambler Surgical - 00190660079376

Harrington thoracic clamp forceps, 12'', heavy, angled, serrated jaws, ring handle
AMBLER SURGICAL CORP.
Harrington thoracic clamp forceps
In Commercial Distribution

  • 00190660079376 ()
31-368

  • Dressing/utility forceps, scissors-like, reusable

Ambler Surgical - 00190660075095

Tendon retriever forceps, 7 3/4'', double-action, straight, serrated jaws with 1x2 teeth, ring handle
AMBLER SURGICAL CORP.
Tendon retriever forceps
In Commercial Distribution

  • 00190660075095 ()
45-480

  • Dressing/utility forceps, scissors-like, reusable

Ambler Surgical - 00190660075088

Tendon retriever forceps, 7 3/4'', double-action, curved, serrated jaws with 1x2 teeth, ring handle
AMBLER SURGICAL CORP.
Tendon retriever forceps
In Commercial Distribution

  • 00190660075088 ()
45-481

  • Dressing/utility forceps, scissors-like, reusable

Ambler Surgical - 00190660112141

Tolsdorf bone crusher
AMBLER SURGICAL CORP.
Tolsdorf bone crusher
In Commercial Distribution

  • 00190660112141 ()
43-108

  • Otologic clamp

Ambler Surgical - 00190660112127

Jost crusher/morselizer
AMBLER SURGICAL CORP.
Jost crusher/morselizer
In Commercial Distribution

  • 00190660112127 ()
45-710

  • Otologic clamp

Ambler Surgical - 00190660112066

Cottle cartilage crusher, 2 3/4'', 15.0mm wide, smooth bed
AMBLER SURGICAL CORP.
Cottle cartilage crusher
In Commercial Distribution

  • 00190660112066 ()
43-100

  • Otologic clamp

Ambler Surgical - 00190660112035

Ambler cartilage crusher, 60mm x 30mm
AMBLER SURGICAL CORP.
Ambler cartilage crusher
In Commercial Distribution

  • 00190660112035 ()
43-105

  • Otologic clamp

Ambler Surgical - 00190660111960

Sternal wire twister, 8'', serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Sternal wire twister
In Commercial Distribution

  • 00190660111960 ()
45-551

  • Suturing needle holder, reusable

Ambler Surgical - 00190660111953

Sternal wire twister, 7'', serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Sternal wire twister
In Commercial Distribution

  • 00190660111953 ()
45-550

  • Suturing needle holder, reusable

Ambler Surgical - 00190660111878

Berry wire twister, 8'', serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Berry wire twister
In Commercial Distribution

  • 00190660111878 ()
45-522

  • Suturing needle holder, reusable

Ambler Surgical - 00190660111861

Berry wire twister, 7 1/4'', serrated TC jaws, black ring handle
AMBLER SURGICAL CORP.
Berry wire twister
In Commercial Distribution

  • 00190660111861 ()
45-520

  • Suturing needle holder, reusable

Ambler Surgical - 00190660109455

Dingman wire passer, 6 1/2'', curved
AMBLER SURGICAL CORP.
Dingman wire passer
In Commercial Distribution

  • 00190660109455 ()
43-120

  • Wire/ligature passer, reusable

Ambler Surgical - 00190660109349

Crawford suture ring, 9'' diameter
AMBLER SURGICAL CORP.
Crawford suture ring
In Commercial Distribution

  • 00190660109349 ()
45-675

  • Gastro-urological guidewire, reusable

Ambler Surgical - 00190660109318

Berci fascial closure instrument, 17cm, size 2.8mm, ring handle
AMBLER SURGICAL CORP.
Berci fascial closure instrument
In Commercial Distribution

  • 00190660109318 ()
43-585

  • Gastro-urological guidewire, reusable
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