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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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NA - 05415067027122

DRG External Pulse Generator, 8 Channel
ST. JUDE MEDICAL, INC.
7599
In Commercial Distribution

  • 05415067027122 ()
7599

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

SJM™ - 05415067023667

DBS External Pulse Generator, 16 Channel
ST. JUDE MEDICAL, INC.
6599
In Commercial Distribution

  • 05415067023667 ()
6599

  • Deep brain electrical stimulation system

Odontit - D914HICS0

Cover Screw - External Hex 0,048" hex
ODONTIT S.A.
HICS
In Commercial Distribution

  • D914HICS0 ()
HICS

  • Screw endosteal dental implant, two-piece

Distender II Barostat - 00627843670896

External Reservoir Unit 1300/120 mL
G&J Electronics Inc
ERU-1300-120
In Commercial Distribution

  • 00627843670896 ()


  • Gastrointestinal barostat

BioHorizons - 00847236000288

External 5.0mm Ball Abutment, 6mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
265-006
Not in Commercial Distribution

  • 00847236000288 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236000271

External 4.0mm Ball Abutment, 6mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
264-006
Not in Commercial Distribution

  • 00847236000271 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236000264

External 3.5mm Ball Abutment, 6mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
263-006
Not in Commercial Distribution

  • 00847236000264 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002626

External 5.0mm Ball Abutment, 4mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
265-004
Not in Commercial Distribution

  • 00847236002626 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002619

External 5.0mm Ball Abutment, 2mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
265-002
Not in Commercial Distribution

  • 00847236002619 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002602

External 4.0mm Ball Abutment, 4mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
264-004
Not in Commercial Distribution

  • 00847236002602 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002596

External 4.0mm Ball Abutment, 2mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
264-002
Not in Commercial Distribution

  • 00847236002596 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002589

External 3.5mm Ball Abutment, 4mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
263-004
Not in Commercial Distribution

  • 00847236002589 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002572

External 3.5mm Ball Abutment, 2mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
263-002
Not in Commercial Distribution

  • 00847236002572 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002503

External 6.0mm Direct Pick-up Coping, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
246-331
In Commercial Distribution

  • 00847236002503 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002497

External 6.0mm Direct Pick-up Coping, Non-hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
246-321
In Commercial Distribution

  • 00847236002497 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002480

External 5.0mm Direct Pick-up Coping, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
245-331
In Commercial Distribution

  • 00847236002480 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002473

External 5.0mm Direct Pick-up Coping, Non-hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
245-321
In Commercial Distribution

  • 00847236002473 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002466

External 4.0mm Direct Pick-up Coping, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
244-331
In Commercial Distribution

  • 00847236002466 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002459

External 4.0mm Direct Pick-up Coping, Non-hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
244-321
In Commercial Distribution

  • 00847236002459 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002435

External 3.5mm Direct Pick-up Coping, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
243-331
In Commercial Distribution

  • 00847236002435 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002428

External 3.5mm Direct Pick-up Coping, Non-hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
243-321
In Commercial Distribution

  • 00847236002428 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BioHorizons - 00847236002220

External 5.0mm Straight Esthetic Abutment, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
225-314
Not in Commercial Distribution

  • 00847236002220 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002213

External 5.0mm Angled Esthetic Abutment, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
225-313
In Commercial Distribution

  • 00847236002213 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002206

External 4.0mm Straight Esthetic Abutment, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
224-314
Not in Commercial Distribution

  • 00847236002206 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002190

External 4.0mm Angled Esthetic Abutment, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
224-313
In Commercial Distribution

  • 00847236002190 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002183

External 3.5mm Straight Esthetic Abutment, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
223-314
Not in Commercial Distribution

  • 00847236002183 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002176

External 3.5mm Angled Esthetic Abutment, Hexed
BIOHORIZONS IMPLANT SYSTEMS, INC
223-313
In Commercial Distribution

  • 00847236002176 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236002169

External 4.0/5.0/6.0mm Ball-top Screw
BIOHORIZONS IMPLANT SYSTEMS, INC
214-235
In Commercial Distribution

  • 00847236002169 ()


  • Dental prosthesis/implant abutment screw analog, reusable

BioHorizons - 00847236001902

External 4.0/5.0/6.0mm Abutment Screw
BIOHORIZONS IMPLANT SYSTEMS, INC
140-300
In Commercial Distribution

  • 00847236001902 ()


  • Dental implant suprastructure, permanent, preformed

U2™ Knee - 04719872174615

External rotation guide , 3° x 11mm
UNITED ORTHOPEDIC CORP.
9303-2411-RD
In Commercial Distribution

  • 04719872174615 ()

  • 3° x 11mm
9303-2411-RD

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174608

External rotation guide, 3° X 9mm
UNITED ORTHOPEDIC CORP.
9303-2409-RE
In Commercial Distribution

  • 04719872174608 ()

  • 3° X 9mm
9303-2409-RE

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174592

External rotation guide , 3° x 9mm
UNITED ORTHOPEDIC CORP.
9303-2409-RD
In Commercial Distribution

  • 04719872174592 ()

  • 3° x 9mm
9303-2409-RD

  • Orthopaedic fixation implant alignment tool

Trulife - 00645517612874

ActiveFlow External Breast Form Size 14
Trulife Limited
0063014
In Commercial Distribution

  • 00645517612874 ()


  • External breast prosthesis

Trulife - 00645517612850

ActiveFlow External Breast Form Size 13
Trulife Limited
0063013
In Commercial Distribution

  • 00645517612850 ()


  • External breast prosthesis

Trulife - 00645517612836

ActiveFlow External Breast Form Size 12
Trulife Limited
0063012
In Commercial Distribution

  • 00645517612836 ()


  • External breast prosthesis

Trulife - 00645517612812

ActiveFlow External Breast Form Size 11
Trulife Limited
0063011
In Commercial Distribution

  • 00645517612812 ()


  • External breast prosthesis

Trulife - 00645517612799

ActiveFlow External Breast Form Size 10
Trulife Limited
0063010
In Commercial Distribution

  • 00645517612799 ()


  • External breast prosthesis

Trulife - 00645517612775

ActiveFlow External Breast Form Size 09
Trulife Limited
0063009
In Commercial Distribution

  • 00645517612775 ()


  • External breast prosthesis

Trulife - 00645517612751

ActiveFlow External Breast Form Size 08
Trulife Limited
0063008
In Commercial Distribution

  • 00645517612751 ()


  • External breast prosthesis

Trulife - 00645517612737

ActiveFlow External Breast Form Size 07
Trulife Limited
0063007
In Commercial Distribution

  • 00645517612737 ()


  • External breast prosthesis
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