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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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ZKSK - 06934415023054

Disposable Ligation Device
Beijing ZKSK Technology Co.,Ltd
HE15-195-1
In Commercial Distribution

  • 06934415023054 ()


  • Polypectomy endoscopic ligator, single-use

ZKSK - 06934415023047

Disposable Ligation Device
Beijing ZKSK Technology Co.,Ltd
HE15-165-3
In Commercial Distribution

  • 06934415023047 ()


  • Polypectomy endoscopic ligator, single-use

ZKSK - 06934415023030

Disposable Ligation Device
Beijing ZKSK Technology Co.,Ltd
HE15-165-2
In Commercial Distribution

  • 06934415023030 ()


  • Polypectomy endoscopic ligator, single-use

ZKSK - 06934415023023

Disposable Ligation Device
Beijing ZKSK Technology Co.,Ltd
HE15-165-1
In Commercial Distribution

  • 06934415023023 ()


  • Polypectomy endoscopic ligator, single-use

Integra Expandable Interbody - 10889981049591

Guide Hex Rod. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2205
Not in Commercial Distribution

  • 10889981049591 ()
98-2205

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

VANGUARD INSTRUMENTS - 00880304610460

No Description
Biomet Orthopedics, LLC
32-480151
In Commercial Distribution

  • 00880304610460 ()
32-480151

  • Bone-resection orthopaedic reamer, reusable

COMPREHENSIVE INSTRUMENTATION - 00880304469976

No Description
Biomet Orthopedics, LLC
405890
In Commercial Distribution

  • 00880304469976 ()
405890

  • Bone-resection orthopaedic reamer, reusable

COMPREHENSIVE INSTRUMENTATION - 00880304471191

No Description
Biomet Orthopedics, LLC
405806
In Commercial Distribution

  • 00880304471191 ()
405806

  • Bone-resection orthopaedic reamer, reusable

ARCOS MODULAR REVISION SYSTEM - 00880304490383

No Description
Biomet Orthopedics, LLC
31-301362
In Commercial Distribution

  • 00880304490383 ()

  • SIZE B
31-301362

  • Bone-resection orthopaedic reamer, reusable

ARCOS MODULAR REVISION SYSTEM - 00880304490222

No Description
Biomet Orthopedics, LLC
31-301363
In Commercial Distribution

  • 00880304490222 ()

  • SIZE C
31-301363

  • Bone-resection orthopaedic reamer, reusable
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