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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 Thing Silver (Polarized) Spectacle
Kenmark Optical, Inc.
OTHGSI52
In Commercial Distribution

  • 00715317176217 ()


  • Tinted non-prescription spectacles
One Thing Gold (Polarized) Spectacle
Kenmark Optical, Inc.
OTHGYG52
In Commercial Distribution

  • 00715317176170 ()


  • Tinted non-prescription spectacles
kit only has one meter
BIONIME CORPORATION
GM291
In Commercial Distribution

  • 00883489002525 ()
  • 00883489002518 ()
  • 10883489002522 ()
  • 20883489002529 ()


  • Glucose monitoring system IVD, home-use
Reline One Instrument Set - Alpha
Nuvasive, Inc.
ALPRELONEIN
In Commercial Distribution

  • 00195377098443 ()


  • Device sterilization/disinfection container, reusable
One Touch Ultra Control Solution
LifeScan Europe GmbH
010-458
In Commercial Distribution

  • 20353885458027 ()
  • 00353885458023 ()
  • 53885-458-02 ()
  • 80353885458029 ()
010-458

  • Glucose monitoring system IVD, point-of-care
One Touch Lancing Device Warr
LifeScan Europe GmbH
021-242
In Commercial Distribution

  • 00353885012126 ()
  • 20353885012120 ()


  • Manual blood lancing device, reusable
One Touch Ultra Control Solution
LifeScan Europe GmbH
021-416
In Commercial Distribution

  • 20353885006235 ()
  • 00353885006231 ()
  • 53885-937-01 ()
021-416

  • Glucose monitoring system IVD, point-of-care
HEATH Chalazion Curette, one sharp and one blunt edge, size 3, 3mm, 4"
BR Surgical, LLC
BR42-10413
In Commercial Distribution

  • 00840183513436 ()
BR42-10413

  • Ophthalmic curette, reusable
8.3 inch Fomon Rasp, Double Ended, One Convex, One Flat, Tip Width 7.5mm
Surgical Direct, Inc.
SD921377100
In Commercial Distribution

  • B382SD9213771000 ()
SD921377100

  • Orthopaedic osteotome
Oxygen Tubing Kink Resistant 15" W One Standard Connector and One Universal Connector
Twin Med, LLC
010-SASA676
In Commercial Distribution

  • 30840330700611 ()
  • 10840330700617 ()
010-SASA676

  • Oxygen administration tubing
Oxygen Tubing Kink Resistant 21" W One Standard Connector and One Universal Connector
Twin Med, LLC
1002057
In Commercial Distribution

  • 30840330700604 ()
  • 10840330700600 ()
1002057

  • Oxygen administration tubing
A set of one Accuryn Monitor High Mount and one Accuryn Floor Stand
POTRERO MEDICAL, INC.
FGN-06-102111
In Commercial Distribution

  • 00850019755251 ()
FGN-06-102111

  • Portable active medical device mount
VITEK DENSICHEK CONNECTIVITY BASE Kit that include one pod and one connecrtivity base
BIOMERIEUX , INC.
422221
In Commercial Distribution

  • 03573026605674 ()


  • Photometer, absorbance/transmission, automated
One 1 FL OZ Conditioning, One 0.33 FL OZ Cleaner, 1 Lens Case
Bausch & Lomb Incorporated
7469
In Commercial Distribution

  • 00047144074696 ()
FCP-4086

  • Contact lens care kit
One 1 FL OZ Conditioning, One 0.33 FL OZ Cleaner, 1 Lens Case
Bausch & Lomb Incorporated
7420
In Commercial Distribution

  • 00047144074207 ()
FCP-4086

  • Contact lens care kit
Blue Polypropylene Monofilament Size 0 one TC-43 needle & one HR26 needle 36" BSC
TELEFLEX INCORPORATED
IPN056767
In Commercial Distribution

  • 24026704735321 ()
  • 14026704735324 ()

  • Suture Length 36", Needle 1 Length 0.160", Needle 2 Length 1.030"
833-235

  • Polyolefin/fluoropolymer suture, monofilament
Green Polyester Braid Size 0 one TC-43 needle & one HR26 needle 36" BSC
TELEFLEX INCORPORATED
IPN056765
In Commercial Distribution

  • 04026704735303 ()
  • 14026704735300 ()

  • Suture Length 36", Needle 1 Length 0.160", Needle 2 Length 1.030"
833-224

  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
One spike to one female luer with 12cm SCD Tubing, case of 50
ORIGEN BIOMEDICAL, INC.
F-S12
Not in Commercial Distribution

  • 10816203022339 ()
  • 20816203022336 ()


  • Blood transfer set
Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL. Distributed under REGARD Brand.
Coopersurgical, Inc.
733776
In Commercial Distribution

  • 20888937027055 ()
  • 60888937027053 ()


  • Laparoscopic wound closure thread
VG BRST TABLE 1.5T 16CH GE450 FUL SET w GRID one patient support assembly, one box of 10 sterilized biopsy grids, one Lateral Array coil Right and Left, one Medial Array coil, one 16Ch interface box, Lateral single loop coil Left and Right, and one medial plug.
Philips Medical Systems Nederland B.V.
989603217111
In Commercial Distribution

  • 00884838119819 ()


  • MRI system coil, radio-frequency
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810605 ()

  • Catheter Working Length: 110 Centimeter
  • Catheter Gauge: 8 French
80239

  • Mechanical atherectomy system catheter/handpiece
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 85 cm), one guidewire (0.018” diameter; 220cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810599 ()

  • Catheter Working Length: 85 Centimeter
  • Catheter Gauge: 8 French
80238

  • Mechanical atherectomy system catheter/handpiece
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810575 ()

  • Catheter Working Length: 110 Centimeter
  • Catheter Gauge: 6 French
80236

  • Mechanical atherectomy system catheter/handpiece
Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long; one 00858086006252 Headframe Kit; and one Couch Adapter
VARIAN MEDICAL SYSTEMS, INC.
P1006805006
In Commercial Distribution

  • 00858086006313 ()


  • Stereotactic radiosurgical invasive head frame
Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), one PermaSoft Soft Denture Liner Kit (N811100), and one Eclipse Bonding Agent Kit (905550), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package with Bonding Agent
Not in Commercial Distribution

  • D0019056450 ()
905645

  • Dental appliance fabrication material, resin
Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), and one PermaSoft Soft Denture Liner Kit (N811100), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package
Not in Commercial Distribution

  • D0019055850 ()
905585

  • Dental appliance fabrication material, resin
Thigh Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1884MFCC
In Commercial Distribution

  • 00810010922595 ()
1884MFCC

  • Aneroid manual sphygmomanometer
Infant Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1882MFCC
In Commercial Distribution

  • 00810010922557 ()
1882MFCC

  • Aneroid manual sphygmomanometer
Child Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1881MFCC
In Commercial Distribution

  • 00810010922526 ()
1881MFCC

  • Aneroid manual sphygmomanometer
Adult Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1880MFCC
In Commercial Distribution

  • 00810010922502 ()
1880MFCC

  • Aneroid manual sphygmomanometer
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