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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® Redensity - 07640173234197

"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173234180) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2
In Commercial Distribution

  • 07640173234197 ()
940056/02

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 3 - 07640173234173

"One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234166) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2
In Commercial Distribution

  • 07640173234166 ()
  • 07640173234173 ()
940008/04

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® Redensity - 07640173233763

"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233794) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2
In Commercial Distribution

  • 07640173233763 ()
  • 07640173233794 ()
940056/01

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 4 - 07640173233756

"One box of RHA® 4 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 07640173233800) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2
Not in Commercial Distribution

  • 07640173233756 ()
  • 07640173233800 ()
940083/01

  • 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

RHA® 4 - 07640173232704

"One box of RHA® 4 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 07640173232698) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 4 US 1.2ml Schott/2 needles TSK 27G1/2
Not in Commercial Distribution

  • 07640173232698 ()
  • 07640173232704 ()
940083

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® Redensity - 07640173231653

"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173230083) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2
Not in Commercial Distribution

  • 07640173230083 ()
  • 07640173231653 ()
940056

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) - 00857335005008

The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
Otsuka America Pharmaceutical Inc
01
In Commercial Distribution

  • 00857335005008 ()
  • 10857335005029 ()


  • Helicobacter pylori urease IVD, kit, chromogenic
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