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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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LIPOSUCTION CANNULA WITH ONE HOLE STRAIGHT
SONTEC INSTRUMENTS, INC.
201-006
Not in Commercial Distribution

  • B0992010060 ()

  • 180x2mm Tip
  • Length: 15.75 Inch


  • Liposuction system cannula, reusable
LIPOSUCTION CANNULA WITH ONE HOLE STRAIGHT
SONTEC INSTRUMENTS, INC.
201-002
Not in Commercial Distribution

  • B0992010020 ()

  • 150x2mm Tip
  • Length: 15.75 Inch


  • Liposuction system cannula, reusable
Reflex One, Skin Stapler, 35 regular
Conmed Corporation
8035
In Commercial Distribution

  • 10653405036920 ()
  • 20653405036927 ()
  • 00653405036923 ()
8035

  • Skin stapler/staple, non-bioabsorbable
Reflex One, Skin Stapler, 35 wide
Conmed Corporation
8535
In Commercial Distribution

  • 10653405036951 ()
  • 20653405036958 ()
  • 00653405036954 ()
8535

  • Skin stapler/staple, non-bioabsorbable
Hoopla Retractor, One Size, 10-Pack, EDU
ZYRIS, INC.
CIR0101
In Commercial Distribution

  • 10810032660458 ()
  • 00810032660451 ()
CIR0101

  • Hand-held dental retractor
Reflex One, Skin Stapler, 35 regular
Conmed Corporation
3036R
In Commercial Distribution

  • 10653405050599 ()
  • 20653405050596 ()
  • 00653405050592 ()
3036R

  • Skin stapler/staple, non-bioabsorbable
Reflex One, Skin Stapler, 35 wide
Conmed Corporation
3036
In Commercial Distribution

  • 10653405048381 ()
  • 20653405048388 ()
  • 00653405048384 ()
3036

  • Skin stapler/staple, non-bioabsorbable
One Step HCG Urine Test Midstream
Guangzhou Decheng Biotechnology Co., LTD
0741M4X003
Not in Commercial Distribution

  • 06974464590084 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
UNO One piece implant insertion tool
MIS Implants Technologies Ltd.
MT-HKO21
Not in Commercial Distribution

  • 07290109016375 ()
MT-HKO21

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
UNO One piece implant long key
MIS Implants Technologies Ltd.
MT-HKL21
Not in Commercial Distribution

  • 07290109016368 ()
MT-HKL21

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
UNO One piece implant short key
MIS Implants Technologies Ltd.
MT-RKS15
Not in Commercial Distribution

  • 07290109014647 ()
MT-RKS15

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
UNO One piece implant long key
MIS Implants Technologies Ltd.
MT-RKL21
Not in Commercial Distribution

  • 07290109014630 ()
MT-RKL21

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
One Source Sterile Ultra-Thin Lancets 30G
RGH ENTERPRISES
ZPL10030OS
In Commercial Distribution

  • 00888499000516 ()
  • 10888499000513 ()

  • Needle Gauge: 30 Gauge
ZPL10030OS

  • Blood lancet, single-use
CPR Shield One Way Valve, Box
Adventure Ready Brands
1
In Commercial Distribution

  • 00814471011362 ()
9999-1601

  • First aid kit, medicated
IPS Style Ceram One 20g 7
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
673362
In Commercial Distribution

673362

  • Dental appliance fabrication material, ceramic
IPS Style Ceram One 100g BL
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
673363
In Commercial Distribution

673363

  • Dental appliance fabrication material, ceramic
CURETTE, RING 3.4MM, CUTTING ONE SIDE
ARTHREX, INC.
AR-21010
In Commercial Distribution

  • 00888867026049 ()
AR-21010

  • Bone curette, reusable
CURRETTE, RING 5.4MM, CUTTING ONE SIDE
ARTHREX, INC.
AR-20010
In Commercial Distribution

  • 00888867025967 ()
AR-20010

  • Bone curette, reusable
Liner Trial Screw, All in One
NEXTSTEP ARTHROPEDIX, LLC
10-95-4026
In Commercial Distribution

  • 00816127024122 ()


  • Acetabulum prosthesis trial, prefabricated, reusable
One Piece Tibial Keel Broach Handle
MODAL MANUFACTURING LLC
Rev A
In Commercial Distribution

  • B035M31205055021 ()
M-3120-5055-02

  • Joint prosthesis implantation kit, reusable
Guide, All In One, Fixed Double
Kalitec Direct LLC
07-K01-5010
In Commercial Distribution

  • B07307K0150100 ()


  • Surgical drill guide, reusable
One step, pre-sterilization handpiece maintenance spray
Scican Ltd
STM500-6NA
In Commercial Distribution

  • 17540196002360 ()
  • 07540196002363 ()
STM500-6NA

  • Surgical instrument maintenance lubricant
One step, pre-sterilization handpiece maintenance spray
Scican Ltd
S500-6NA
In Commercial Distribution

  • 17540196002353 ()
  • 07540196002356 ()
S500-6NA

  • Surgical instrument maintenance lubricant
DSS 400, Instrument Case, One Handpiece
ARTHREX, INC.
AR-400AC
In Commercial Distribution

  • 00888867273948 ()
AR-400AC

  • Instrument tray, reusable
Henry Schein One Step + H. Pylori
HENRY SCHEIN, INC.
5702778
In Commercial Distribution

  • 00304040155745 ()
  • 10304040155742 ()
5702778

  • Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
Cervical Collar. One Size Fits Most.
WALGREEN CO.
277304
In Commercial Distribution

  • 00311917159188 ()
  • 10311917159185 ()
WRX277304V1

  • Cervical spine collar, reusable
Light cure self-etching one component adhesive
Harvard Dental International GmbH
7083609
In Commercial Distribution

  • EHAR70836091 ()
  • 7083609 ()


  • Dentine bonding agent/set
Light cure self-etching one component adhesive
Harvard Dental International GmbH
7083604
In Commercial Distribution

  • EHAR70836041 ()


  • Dentine bonding agent/set
Light cure self-etching one component adhesive
Harvard Dental International GmbH
7083601
In Commercial Distribution

  • EHAR70836011 ()


  • Dentine bonding agent/set
Light cure self-etching one component adhesive
Harvard Dental International GmbH
17766
In Commercial Distribution

  • EHAR177661 ()


  • Dentine bonding agent/set
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