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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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ASCENT LE - 18257200064625

3.5MM X 48MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3748
In Commercial Distribution

  • 18257200064625 ()


  • Bone-screw internal spinal fixation system, non-sterile

ASCENT LE - 18257200064618

3.5MM X 46MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3746
In Commercial Distribution

  • 18257200064618 ()


  • Bone-screw internal spinal fixation system, non-sterile

ASCENT LE - 18257200064601

3.5MM X 44MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3744
In Commercial Distribution

  • 18257200064601 ()


  • Bone-screw internal spinal fixation system, non-sterile

ASCENT LE - 18257200064595

3.5MM X 42MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3742
In Commercial Distribution

  • 18257200064595 ()


  • Bone-screw internal spinal fixation system, non-sterile

Alleset - 16931918164595

Sustainable Surgical Sponge Bowl_1000 cc (32oz)_Non-sterile_340ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Ei15-1000
In Commercial Distribution

  • 06931918164598 ()
  • 16931918164595 ()


  • General-purpose bowl, single-use

Real Intelligence - 00885556775400

JOURNEY II XR POLY TRIAL INSERT RIGHT (CC)
Smith & Nephew, Inc.
ROB10080
In Commercial Distribution

  • 00885556775400 ()
ROB10080

  • Instrument tray, reusable

Real Intelligence - 00885556775394

JOURNEY II XR POLY TRIAL INSERT LEFT (CC)
Smith & Nephew, Inc.
ROB10079
In Commercial Distribution

  • 00885556775394 ()
ROB10079

  • Instrument tray, reusable

5-Pack, 100 cc Syringe, Luer-locking - 00851607003518

Syringe, Luer-Locking, 100cc, 5-Pack
MEDSPIRA, LLC
RMD-010-016
In Commercial Distribution

  • 10851607003515 ()
  • 00851607003518 ()


  • Manometric gastrointestinal motility analysis system

Gaard Lock PET 10 cc - 00859942006935

Tungsten Syringe Shield for PET with Flanged Locking Mechanism
Mirion Technologies (capintec), Inc.
007-713
In Commercial Distribution

  • 00859942006935 ()
007-713

  • Syringe radiation shield

Gaard Lock PET 3 cc - 00859942006911

Tungsten Syringe Shield for PET with Flanged Locking Mechanism
Mirion Technologies (capintec), Inc.
007-711
In Commercial Distribution

  • 00859942006911 ()
007-711

  • Syringe radiation shield
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