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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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RHA® 2 - 07640173233671

"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233695) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 2 US 1ml Schott/2 aig. TSK 30G1/2
In Commercial Distribution

  • 07640173233671 ()
  • 07640173233695 ()
940007/01

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 2 - 07640173230021

One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173230014) is defined as unit of sales and identified with a serial number.
Teoxane SA
RHA® 2 (1mL)
Not in Commercial Distribution

  • 07640173230021 ()
  • 07640173230014 ()
940007

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

ROMEO 2 INSTRUMENTATION - 07640178985742

Long Screwdriver Sleeve
SpineArt SA
SPE-IN 01 74-N
In Commercial Distribution

  • 07640178985742 ()
SPE-IN 01 74-N

  • Surgical screwdriver, reusable

ROMEO 2 INSTRUMENTATION - 07640178985735

Long Screwdriver Tube
SpineArt SA
SPE-IN 01 73-N
In Commercial Distribution

  • 07640178985735 ()
SPE-IN 01 73-N

  • Surgical screwdriver, reusable

ROMEO 2 INSTRUMENTATION - 07640178985728

Long Screwdriver Shaft
SpineArt SA
SPE-IN 01 72-N
In Commercial Distribution

  • 07640178985728 ()
SPE-IN 01 72-N

  • Surgical screwdriver, reusable

ROMEO 2 MIS - 07640178985018

Trocar awl
SpineArt SA
MIS-IN 52 13-N
In Commercial Distribution

  • 07640178985018 ()


  • Bone awl, reusable

ROMEO 2 MIS - 07640178985001

Trocar needle
SpineArt SA
MIS-IN 52 12-N
In Commercial Distribution

  • 07640178985001 ()


  • Bone awl, reusable

ROMEO 2 MIS - 07640178984998

Needle cap
SpineArt SA
MIS-IN 52 11-N
In Commercial Distribution

  • 07640178984998 ()


  • Bone awl, reusable

ROMEO 2 MIS - 07640178984981

Trocar Handle
SpineArt SA
MIS-IN 52 10-N
In Commercial Distribution

  • 07640178984981 ()


  • Bone awl, reusable

ROMEO 2 INSTRUMENTATION - 07640178983526

SETSCREW HOLDER T
SpineArt SA
ELL-IN 06 10-N
In Commercial Distribution

  • 07640178983526 ()
ELL-IN 06 10-N

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