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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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BIRMINGHAM HIP RESURFACING (BHR) - 03596010559227

BHR SLEEVE CUTTER SIZE 44
Smith & Nephew, Inc.
90129257
In Commercial Distribution

  • 03596010559227 ()
90129257

  • Bone-resection orthopaedic reamer, reusable

BIRMINGHAM HIP RESURFACING (BHR) - 03596010559210

BHR SLEEVE CUTTER SIZE 40
Smith & Nephew, Inc.
90129256
In Commercial Distribution

  • 03596010559210 ()
90129256

  • Bone-resection orthopaedic reamer, reusable

GYNECARE THERMACHOICE - 10705031050730

With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter

UNIPURE & UNIPEXY - 00380657530687

UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753068
In Commercial Distribution

  • 10380657530684 ()
  • 00380657530687 ()
8065753068

  • Perfluoropropane refillable cylinder

UNIPURE & UNIFEYE - 00380657530663

UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753066
In Commercial Distribution

  • 10380657530660 ()
  • 00380657530663 ()
8065753066

  • Perfluoropropane refillable cylinder

UNIPURE & UNIPEXY - 00380657530694

UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753069
In Commercial Distribution

  • 10380657530691 ()
  • 00380657530694 ()
8065753069

  • Sulfur hexafluoride refillable cylinder

UNIPURE & UNIFEYE - 00380657530670

UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753067
In Commercial Distribution

  • 10380657530677 ()
  • 00380657530670 ()
8065753067

  • Sulfur hexafluoride refillable cylinder

PRESTIGE® LP Cervical Disc System - 00613994490728

PUNCH 6972426 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972426
In Commercial Distribution

  • 00613994490728 ()


  • Bone-resection orthopaedic reamer, reusable

PRESTIGE LP™ - 00613994490711

PUNCH 6972445 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972445
In Commercial Distribution

  • 00613994490711 ()

  • Height: 5.0 Millimeter


  • Bone-resection orthopaedic reamer, reusable

PRESTIGE® LP Cervical Disc System - 00613994490704

PUNCH 6972446 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972446
In Commercial Distribution

  • 00613994490704 ()


  • Bone-resection orthopaedic reamer, reusable
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