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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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Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB2-L
In Commercial Distribution

  • 08809186542067 ()

  • 8mm X 7mm X 9mm


  • Dental bone matrix implant, animal-derived
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP2-L
In Commercial Distribution

  • 08809186542043 ()

  • 12mm X 25mm


  • Dental bone matrix implant, animal-derived
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types,Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB1-S
In Commercial Distribution

  • 08809186542050 ()

  • 6mm X 5mm X 7mm


  • Dental bone matrix implant, animal-derived
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP1-S
In Commercial Distribution

  • 08809186542036 ()

  • 8mm X 18mm


  • Dental bone matrix implant, animal-derived
DRIVER 9098061 HEX STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
9098061
In Commercial Distribution

  • 00681490993616 ()


  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
31-476946
In Commercial Distribution

  • 00880304008984 ()
31-476946

  • Orthopaedic implant driver
INSTRUMENT 8951808 18MM DRIVER SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
8951808
In Commercial Distribution

  • 00681490907149 ()


  • Orthopaedic implantation sleeve, reusable
T-HANDLE W/ MINI HUDSON QC
MEDTRONIC SOFAMOR DANEK, INC.
X0101012
In Commercial Distribution

  • 00681490906753 ()


  • Orthopaedic implant driver
INSTRUMENT 8950003 TAPRD IMP DRVR WRENCH
MEDTRONIC SOFAMOR DANEK, INC.
8950003
In Commercial Distribution

  • 00681490904810 ()


  • Orthopaedic implant driver
INSTRUMENT 8950001 DBL DISTRCTR DRVR CAP
MEDTRONIC SOFAMOR DANEK, INC.
8950001
In Commercial Distribution

  • 00681490904803 ()


  • Orthopaedic implant driver
DRIVER 8001205 MOD SHAFT 1.6MM
MEDTRONIC PS MEDICAL, INC.
8001205
In Commercial Distribution

  • 00681490904384 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 8001201 HANDL MOD TIMESH
MEDTRONIC PS MEDICAL, INC.
8001201
In Commercial Distribution

  • 00681490904360 ()


  • General internal orthopaedic fixation system implantation kit
M8 MAS DRIVER W/ BALL DETENT
MEDTRONIC SOFAMOR DANEK, INC.
X1000007
In Commercial Distribution

  • 00681490902250 ()


  • Orthopaedic implant driver
NON CANN. DRIVER W/2.5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
X0900023
In Commercial Distribution

  • 00681490902168 ()


  • Orthopaedic implant driver
M8 INST 8680926 SPLIT T25 DRIVER SHT
MEDTRONIC SOFAMOR DANEK, INC.
8680926
In Commercial Distribution

  • 00681490901482 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9680927 SOLID T30 QUICK ECT
MEDTRONIC SOFAMOR DANEK, INC.
9680927
In Commercial Distribution

  • 00681490885638 ()


  • Orthopaedic implant driver
INSTRUMENT 8951607 REAMER PLUG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
8951607
In Commercial Distribution

  • 00681490847100 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8950005 SGL BARRL OS DRVR CAP
MEDTRONIC SOFAMOR DANEK, INC.
8950005
In Commercial Distribution

  • 00681490846851 ()


  • Orthopaedic implant driver
LOCKSCREW DRIVER W/MOD HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1100015
In Commercial Distribution

  • 00681490570152 ()


  • Orthopaedic implant driver
SCREWDRIVER W/SOLID HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1100014
In Commercial Distribution

  • 00681490570145 ()


  • Orthopaedic implant driver
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