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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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digene® Wash Buffer Concentrate - 14053228002014

digene® Wash Buffer Concentrate (paired with 5199-00016 High-risk 4-plate)
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002014 ()
5100-00047

  • Human papillomavirus (HPV) antigen IVD, reagent

Impella - 00813502011142

Packaged Slit Silicone Plugs (bx of 5)
Abiomed, Inc.
0046-3030
In Commercial Distribution

  • 00813502011142 ()
  • 00813502012088 ()
0046-3030

  • Catheter orifice occluder

RHA® 3 Mepi - 07640173236177

"One box of RHA® 3 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173236108) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 Mepi - TSK - US
In Commercial Distribution

  • 07640173236108 ()
  • 07640173236177 ()
940195

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 2 Mepi - 07640173233527

"One box of RHA® 2 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233442) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 2 Mepi - Terumo - US
In Commercial Distribution

  • 07640173233442 ()
  • 07640173233527 ()
940099

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® Redensity™ Mepi - 07640173233497

"One box of RHA® Redensity™ Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233367) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® Redensity Mepi - Terumo - US
In Commercial Distribution

  • 07640173233367 ()
  • 07640173233497 ()
940034

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 4 Mepi - 07640173233480

"One box of RHA® 4 Mepi contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233411) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 4 Mepi - TSK - US
In Commercial Distribution

  • 07640173233411 ()
  • 07640173233480 ()
940033

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 3 Mepi - 07640173233473

"One box of RHA® 3 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233398) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 Mepi - TSK - US
In Commercial Distribution

  • 07640173233398 ()
  • 07640173233473 ()
940031

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

UroVysion - 00884999002180

UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-095
In Commercial Distribution

  • 00884999002180 ()
02J27-095

  • Bladder tumour-associated mutation IVD, probe

UroVysion - 00884999002142

UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-025
In Commercial Distribution

  • 00884999002142 ()
02J27-025

  • Bladder tumour-associated mutation IVD, probe

Sterishot (Femcare) for Minilaparotomy - 15055515602340

Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator ONLY as part of a kit.
FEMCARE LIMITED
AVM-600M
In Commercial Distribution

  • 15055515602340 ()
AVM-600M

  • Fallopian tube clip/band
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