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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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One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173230052) is defined as unit of sales and identified with a serial number.
Teoxane SA
RHA® 4 (1mL)
Not in Commercial Distribution

  • 07640173230069 ()
  • 07640173230052 ()
940009

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Radiesse Injectable Implant is a volumizing filler intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.
MERZ NORTH AMERICA, INC.
8071M0H1
In Commercial Distribution

  • M2138071M0H15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K1
In Commercial Distribution

  • M2138063M0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: 1 g n-BCA, self-piercing cap, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels
Cerenovus, Inc.
632500NA
In Commercial Distribution

  • 10886704085317 ()
632500NA

  • Neurovascular embolization plug
"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
"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
"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
"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
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K2
In Commercial Distribution

  • M2138063M0K25 ()
  • M2138063M0K22 ()

  • Total Volume: 3.0 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
BAXTER HEALTHCARE CORPORATION
1514243
In Commercial Distribution

  • 35413765583415 ()
  • 05413765583414 ()
  • 55413765583419 ()
1514243

  • Open-surgery adhesive/sealant applicator, dual-channel
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