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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Knurled Spring & Thumb Screw for D1/D2/V2 Knee Positioners - 6 ea
Innovative Medical Products, Inc
803-114-SS-6
In Commercial Distribution

  • 10696588006038 ()
803-114-SS-6

  • Leg procedure positioner
Versaport V2 RT 5 mm Obturator with 5 mm Seal 3/bx
STERILMED, INC.
AUT179101-3
Not in Commercial Distribution

  • 20888551044285 ()
AUT179101-3

  • Laparoscopic access cannula, reprocessed
Versaport V2 12mm Trocar with Fixation Cannula and Universal Seal 3/bx
STERILMED, INC.
AUT179096PF-3
Not in Commercial Distribution

  • 20888551044278 ()
AUT179096PF-3

  • Laparoscopic trocar blade, reprocessed
Versaport V2 11mm Trocar with Fixation Cannula and Universal Seal 3/bx
STERILMED, INC.
AUT179095PF-3
Not in Commercial Distribution

  • 20888551044261 ()
AUT179095PF-3

  • Laparoscopic trocar blade, reprocessed
Esteem®+ Flex Convex, One Piece Urostomy System, Drainable, V2 Pre-Cut, 15Mm
CONVATEC, PURCHASING DEPARTMENT
421627
In Commercial Distribution

  • 10768455143457 ()
  • 00768455143450 ()
  • 00768455197569 ()


  • One-piece urostomy bag, open-ended
Esteem®+ Flex Convex, One Piece Urostomy System, Drainable, V2 Cut-To-Fit, 10-35Mm
CONVATEC, PURCHASING DEPARTMENT
421626
In Commercial Distribution

  • 10768455143433 ()
  • 00768455143436 ()
  • 00768455197552 ()


  • One-piece urostomy bag, open-ended
Esteem®+ Flex Convex, One Piece Ostomy System, Drainable, V2 Pre-Cut, 30Mm
CONVATEC, PURCHASING DEPARTMENT
421621
In Commercial Distribution

  • 10768455143334 ()
  • 00768455143337 ()
  • 00768455197507 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Flex Convex, One Piece Ostomy System, Drainable, V2 Pre-Cut, 25Mm
CONVATEC, PURCHASING DEPARTMENT
421620
In Commercial Distribution

  • 10768455143310 ()
  • 00768455143313 ()
  • 00768455197491 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Flex Convex, One Piece Ostomy System, Drainable, V2 Cut-To-Fit, 20-35Mm
CONVATEC, PURCHASING DEPARTMENT
421619
In Commercial Distribution

  • 10768455143297 ()
  • 00768455143290 ()
  • 00768455197484 ()


  • One-piece intestinal ostomy bag, open-ended
Kit for 5 Neuro V2 treatments performed under 1.5T MRI guidance. Kit content: Part Description SET400315-BB Neuro V2 kit 1.5T US MPR000444-AA HEAD RING SCREWS LONG (sterile)
INSIGHTEC LTD
SET001026-BB MASTER SET NEURO V2 PATIENT TREAT.KITS 1.5T
In Commercial Distribution

  • 07290015461542 ()
SET001026-BB

  • Therapeutic oncological/gynaecological ultrasound system
Kit for 5 Neuro V2 treatments performed under 3T MRI guidance. Kit content: Part Description SET000960-BB Neuro V2 kit 3T US MPR000444-AA HEAD RING SCREWS LONG (sterile)
INSIGHTEC LTD
SET000969-BB NEURO V2 PATIENT TREAT.KITS 3T MASTER SET
In Commercial Distribution

  • 07290015461528 ()
SET000969-BB

  • Therapeutic oncological/gynaecological ultrasound system
Kit for 5 Neuro V2 treatments performed under 3T MRI guidance. Kit content: Part Description SET000960-AA Neuro V2 kit 3T US MPR000444-AA HEAD RING SCREWS LONG (sterile)
INSIGHTEC LTD
SET000969 NEURO V2 PATIENT TREAT.KITS 3T MASTER SET
In Commercial Distribution

  • 07290015461405 ()
SET000969

  • Therapeutic oncological/gynaecological ultrasound system
COSMETIC PLASTIC FACIAL SURGERY GAUGE VISAGE MEASUREMENT CALIPER V-2, RHINOPLASTY, EYES, EAR, LIP.
Power Dental U.S.A. Inc.
4654
In Commercial Distribution

  • D9434654 ()
4654

  • Dressing/utility forceps, scissors-like, reusable
  • General-purpose calliper, metallic
MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012)
STRYKER CORPORATION
PN 11035
In Commercial Distribution

  • 00859506006135 ()


  • Blood loss estimation canister insert/label
Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)
STRYKER CORPORATION
PN 11033
In Commercial Distribution

  • 00859506006104 ()


  • Blood loss estimation canister insert/label
De Mayo V2® Knee Positioner® (30" w/ Spring Handle Assembly & 621)
Innovative Medical Products, Inc
114-621 KIT-SHA
In Commercial Distribution

  • 00696588007380 ()
114-621 KIT-SHA

  • Leg procedure positioner
De Mayo V2® Knee Positioner® (25" w/ 180° Flip Handle Assembly)
Innovative Medical Products, Inc
114-S-907 KIT
In Commercial Distribution

  • 00696588002460 ()
114-S-907 KIT

  • Leg procedure positioner
De Mayo V2® Knee Positioner® (25" w/ 180° Flip Handle Assembly)
Innovative Medical Products, Inc
114-S KIT
In Commercial Distribution

  • 00696588001593 ()
114-S KIT

  • Leg procedure positioner
De Mayo V2® Knee Positioner® (30" w/ 180° Flip Handle Assembly)
Innovative Medical Products, Inc
114 KIT
In Commercial Distribution

  • 00696588001586 ()
114 KIT

  • Leg procedure positioner
De Mayo V2® Knee Positioner® (30" w/ 180° Flip Handle Assembly)
Innovative Medical Products, Inc
114-907 KIT
In Commercial Distribution

  • 00696588001395 ()
114-907 KIT

  • Leg procedure positioner
DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
Beyes Dental Canada Inc
XR2011
In Commercial Distribution

  • 00990010301306 ()
DURAY V2

  • Stationary intraoral dental x-ray system, digital
DURAY V2, MOBILE DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
Beyes Dental Canada Inc
XR2012
In Commercial Distribution

  • 00990010301283 ()
DURAY V2

  • Stationary intraoral dental x-ray system, digital
Thretain TSI Reporter Bioassay 50P
DIAGNOSTIC HYBRIDS, INC.
Thyretain
In Commercial Distribution

  • 30014613331605 ()
40-50000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay
Thretain TSI Reporter Bioassay 25P
DIAGNOSTIC HYBRIDS, INC.
Thyretain
In Commercial Distribution

  • 30014613331537 ()
40-25000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay
ELVIS HSV ID/TYPING TEST SYSTEM
DIAGNOSTIC HYBRIDS, INC.
ELVIS HSV ID / D3 Typing Test System
In Commercial Distribution

  • 30014613336334 ()
SKT-ELVIS-60.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
ELVIS HSV ID/TYPING TEST SYSTEM
DIAGNOSTIC HYBRIDS, INC.
ELVIS HSV ID / D3 Typing Test System
In Commercial Distribution

  • 30014613336327 ()
SKT-ELVIS-300.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
De Mayo V2® Knee Positioner® (25" w/ 180° Flip Handle Assembly & 621)
Innovative Medical Products, Inc
114-S-621 KIT
In Commercial Distribution

  • 00696588007564 ()
114-S-621 KIT

  • Leg procedure positioner
De Mayo V2® Knee Positioner® (30" w/ Spring Handle Assembly, 621 & 907-GP-10)
Innovative Medical Products, Inc
114-621 KIT-SHA-P
In Commercial Distribution

  • 00696588007373 ()
114-621 KIT-SHA-P

  • Leg procedure positioner
OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only)
OTODYNAMICS LIMITED
ON-BATT-KIT
In Commercial Distribution

  • 05060396172809 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
North American Kandyway Eternal Glow MD - Face (V2 Facemask) Legal Manufacturer- I-Smart Developments Ltd
I-SMART DEVELOPMENTS LIMITED
TN19G
In Commercial Distribution

111B

  • Cosmetic red-light phototherapy system, home-use
DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
Beyes Dental Canada Inc
XR2011
In Commercial Distribution

  • 00837699000116 ()


  • Stationary intraoral dental x-ray system, digital
Versaport Plus V2 RT 11 mm Obturator with 5 mm Plus Seal 3/bx
STERILMED, INC.
AUT179102P-3
Not in Commercial Distribution

  • 20888551044254 ()
AUT179102P-3

  • Laparoscopic access cannula, reprocessed
No Description
FORMLABS OHIO INC.
FLDLCL02
In Commercial Distribution

  • 10860002099337 ()
  • 00860002099330 ()
FLDLCL02

  • Dental appliance fabrication material, resin
No Description
Biomet Orthopedics, LLC
152732
In Commercial Distribution

  • 00880304007765 ()

  • 60 MM
152732

  • Cruciate-retaining total knee prosthesis
No Description
Biomet Orthopedics, LLC
155055
In Commercial Distribution

  • 00880304245518 ()

  • 75 MM
155055

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155053
In Commercial Distribution

  • 00880304245495 ()

  • 65 MM
155053

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155052
In Commercial Distribution

  • 00880304245488 ()

  • 60 MM
155052

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155051
In Commercial Distribution

  • 00880304245471 ()

  • 55 MM
155051

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155046
In Commercial Distribution

  • 00880304245440 ()

  • 80 MM
155046

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155044
In Commercial Distribution

  • 00880304245426 ()

  • 70 MM
155044

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155042
In Commercial Distribution

  • 00880304245396 ()

  • 60 MM
155042

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155056
In Commercial Distribution

  • 00880304245525 ()

  • 80 MM
155056

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155054
In Commercial Distribution

  • 00880304245501 ()

  • 70 MM
155054

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155045
In Commercial Distribution

  • 00880304245433 ()

  • 75 MM
155045

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155043
In Commercial Distribution

  • 00880304245402 ()

  • 65 MM
155043

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
155041
In Commercial Distribution

  • 00880304245389 ()

  • 55 MM
155041

  • Posterior-stabilized total knee prosthesis
No Description
Biomet Orthopedics, LLC
152749
In Commercial Distribution

  • 00880304242418 ()

  • 80 MM
152749

  • Cruciate-retaining total knee prosthesis
No Description
Biomet Orthopedics, LLC
152748
In Commercial Distribution

  • 00880304242401 ()

  • 75 MM
152748

  • Cruciate-retaining total knee prosthesis
No Description
Biomet Orthopedics, LLC
152746
In Commercial Distribution

  • 00880304242395 ()

  • 70 MM
152746

  • Cruciate-retaining total knee prosthesis
No Description
Biomet Orthopedics, LLC
152744
In Commercial Distribution

  • 00880304242371 ()

  • 65 MM
152744

  • Cruciate-retaining total knee prosthesis
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