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 PIECE™ IMPLANT ANALOG
INTRA-LOCK INTERNATIONAL, INC.
OPA2
In Commercial Distribution

  • D742OPA20 ()
OPA2

  • Dental implant system
ONE PIECE™ IMPLANT ANALOG
INTRA-LOCK INTERNATIONAL, INC.
OPA
In Commercial Distribution

  • D742OPA0 ()
OPA

  • Dental implant system
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
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
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
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
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
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
One Piece Dental Implant 3.0mm diameter and 17mm in length crown and bridge angled head
Suncoast Dental, Inc
One Piece/3.0 x 17CBA
In Commercial Distribution

  • 00083208330179 ()

  • Outer Diameter: 3 Millimeter
  • One Piece 3.0mm Diameter x 17mm Length CBA
  • Length: 17 Millimeter
ITO 3.0 x 17mm (CBA)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 8.0mm diameter and 14mm in length small ball head
Suncoast Dental, Inc
One Piece/8.0x14SB
Not in Commercial Distribution

  • 00083208280146 ()

  • One Piece 8.0mm Diameter x 14mm Length SB
  • Outer Diameter: 8 Millimeter
  • Length: 14 Millimeter
ITO8.0x14SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 8.0mm diameter and 11mm in length small ball head
Suncoast Dental, Inc
One Piece/8.0x11SB
Not in Commercial Distribution

  • 00083208280115 ()

  • Length: 11 Millimeter
  • One Piece 8.0mm Diameter x 11mm Length SB
  • Outer Diameter: 8 Millimeter
ITO8.0x11SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 6.0mm diameter and 11mm in length small ball head
Suncoast Dental, Inc
One Piece/6.0 x 11SB
Not in Commercial Distribution

  • 00083208260117 ()

  • Outer Diameter: 6 Millimeter
  • Length: 11 Millimeter
  • One Piece 6.0mm Diameter x 11mm Length SB
ITO6.0x11SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 5.0mm diameter and 23mm in length small ball head
Suncoast Dental, Inc
One Piece/5.0x23SB
Not in Commercial Distribution

  • 00083208250231 ()

  • Outer Diameter: 5 Millimeter
  • One Piece 5.0mm Diameter x 20mm Length SB
  • Length: 23 Millimeter
ITO5.0x23SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 5.0mm diameter and 20mm in length small ball head
Suncoast Dental, Inc
One Piece/5.0x20SB
Not in Commercial Distribution

  • 00083208250200 ()

  • One Piece 5.0mm Diameter x 20mm Length SB
  • Length: 20 Millimeter
  • Outer Diameter: 5 Millimeter
ITO5.0x20SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 5.0mm diameter and 17mm in length small ball head
Suncoast Dental, Inc
One Piece/5.0 x 17SB
In Commercial Distribution

  • 00083208250170 ()

  • Outer Diameter: 5 Millimeter
  • One Piece 5.0mm Diameter x 17mm Length SB
  • Length: 17 Millimeter
ITO 5.0 x 17mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 5.0mm diameter and 14mm in length small ball head
Suncoast Dental, Inc
One Piece/5.0 x 14SB
In Commercial Distribution

  • 00083208250149 ()

  • Length: 14 Millimeter
  • One Piece 5.0mm Diameter x 14mm Length SB
  • Outer Diameter: 5 Millimeter
ITO 5.0 x 14mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 5.0mm diameter and 11mm in length small ball head
Suncoast Dental, Inc
One Piece/5.0 x 11SB
In Commercial Distribution

  • 00083208250118 ()

  • One Piece 5.0mm Diameter x 11mm Length SB
  • Outer Diameter: 5 Millimeter
  • Length: 11 Millimeter
ITO 5.0 x 11mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 23mm in length small ball head
Suncoast Dental, Inc
One Piece/4.5x23SB
Not in Commercial Distribution

  • 00083208245237 ()

  • Length: 23 Millimeter
  • One Piece 4.5mm Diameter x 23mm Length SB
  • Outer Diameter: 4.5 Millimeter
ITO4.5x23SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 20mm in length small ball head
Suncoast Dental, Inc
One Piece/4.5x20SB
Not in Commercial Distribution

  • 00083208245206 ()

  • One Piece 4.5mm Diameter x 20mm Length SB
  • Length: 20 Millimeter
  • Outer Diameter: 4.5 Millimeter
ITO4.5x20SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 17mm in length small ball head
Suncoast Dental, Inc
One Piece/4.5x17SB
Not in Commercial Distribution

  • 00083208245176 ()

  • One Piece 4.5mm Diameter x 17mm Length SB
  • Outer Diameter: 4.5 Millimeter
  • Length: 17 Millimeter
ITO4.5x17SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.5mm diameter and 14mm in length small ball head
Suncoast Dental, Inc
One Piece/4.5x14SB
Not in Commercial Distribution

  • 00083208245145 ()

  • One Piece 4.5mm Diameter x 14mm Length SB
  • Length: 14 Millimeter
  • Outer Diameter: 4.5 Millimeter
ITO4.5x14SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.0mm diameter and 20mm in length small ball head
Suncoast Dental, Inc
One Piece/4.0x20SB
Not in Commercial Distribution

  • 00083208240201 ()

  • Outer Diameter: 4 Millimeter
  • One Piece 4.0mm Diameter x 20mm Length SB
  • Length: 20 Millimeter
ITO4.0x20SB

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.0mm diameter and 17mm in length small ball head
Suncoast Dental, Inc
One Piece/4.0 x 17SB
In Commercial Distribution

  • 00083208240171 ()

  • One Piece 4.0mm Diameter x 17mm Length SB
  • Outer Diameter: 4 Millimeter
  • Length: 17 Millimeter
ITO 4.0 x 17mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.0mm diameter and 14mm in length small ball head
Suncoast Dental, Inc
One Piece/4.0 x 14SB
In Commercial Distribution

  • 00083208240140 ()

  • Length: 14 Millimeter
  • One Piece 4.0mm Diameter x 14mm Length SB
  • Outer Diameter: 4 Millimeter
ITO 4.0 x 14mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.0mm diameter and 11mm in length small ball head
Suncoast Dental, Inc
One Piece/4.0 x 11SB
In Commercial Distribution

  • 00083208240119 ()

  • Outer Diameter: 4 Millimeter
  • Length: 11 Millimeter
  • One Piece 4.0mm Diameter x 11mm Length SB
ITO 4.0 x 11mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 23mm in length small ball head
Suncoast Dental, Inc
One Piece/3.5 x 23SB
Not in Commercial Distribution

  • 00083208235238 ()

  • Length: 23 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • One Piece 3.5mm Diameter x 23mm Length SB
ITO 3.5 x 23mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 20mm in length small ball head
Suncoast Dental, Inc
One Piece/3.5 x 20SB
Not in Commercial Distribution

  • 00083208235207 ()

  • Outer Diameter: 3.5 Millimeter
  • One Piece 3.5mm Diameter x 20mm Length SB
  • Length: 20 Millimeter
ITO 3.5 x 20mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 17mm in length small ball head
Suncoast Dental, Inc
One Piece/3.5 x 17SB
In Commercial Distribution

  • 00083208235177 ()

  • Length: 17 Millimeter
  • One Piece 3.5mm Diameter x 17mm Length SB
  • Outer Diameter: 3.5 Millimeter
ITO 3.5 x 17mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 14mm in length small ball head
Suncoast Dental, Inc
One Piece/3.5 x 14SB
In Commercial Distribution

  • 00083208235146 ()

  • One Piece 3.5mm Diameter x 14mm Length SB
  • Outer Diameter: 3.5 Millimeter
  • Length: 14 Millimeter
ITO 3.5 x 14mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 11mm in length small ball head
Suncoast Dental, Inc
One Piece/3.5 x 11SB
In Commercial Distribution

  • 00083208235115 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 11 Millimeter
  • One Piece 3.5mm Diameter x 11mm Length SB
ITO 3.5 x 11mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.0mm diameter and 14mm in length small ball head
Suncoast Dental, Inc
One Piece/3.0 x 14SB
In Commercial Distribution

  • 00083208230141 ()

  • Outer Diameter: 3 Millimeter
  • One Piece 3.0mm Diameter x 14mm Length SB
  • Length: 14 Millimeter
ITO 3.0 x 14mm (SB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 23mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.5 x 23CB
Not in Commercial Distribution

  • 00083208135231 ()

  • Length: 23 Millimeter
  • One Piece 3.5mm Diameter x 23mm Length CB
  • Outer Diameter: 3.5 Millimeter
ITO 3.5 x 23mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 20mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.5 x 20CB
Not in Commercial Distribution

  • 00083208135200 ()

  • Outer Diameter: 3.5 Millimeter
  • One Piece 3.5mm Diameter x 20mm Length CB
  • Length: 20 Millimeter
ITO 3.5 x 20mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 17mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.5 x 17CB
In Commercial Distribution

  • 00083208135170 ()

  • Length: 17 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • One Piece 3.5mm Diameter x 17mm Length CB
ITO 3.5 x 17mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 11mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.5 x 11CB
In Commercial Distribution

  • 00083208135118 ()

  • Length: 11 Millimeter
  • One Piece 3.5mm Diameter x 11mm Length CB
  • Outer Diameter: 3.5 Millimeter
ITO 3.5 x 11mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.0mm diameter and 23mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.0 x 23CB
Not in Commercial Distribution

  • 00083208130236 ()

  • Length: 23 Millimeter
  • Outer Diameter: 3 Millimeter
  • One Piece 3.0mm Diameter x 23mm Length CB
ITO 3.0 x 23mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.0mm diameter and 20mm in length crown and bridge head
Suncoast Dental, Inc
One Piece/3.0 x 20CB
Not in Commercial Distribution

  • 00083208130205 ()

  • Length: 20 Millimeter
  • One Piece 3.0mm Diameter x 20mm Length CB
  • Outer Diameter: 3 Millimeter
ITO 3.0 x 20mm (CB)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.0mm diameter and 17mm in length crown and bridge angled head
Suncoast Dental, Inc
One Piece/4.0 x 17CBA
In Commercial Distribution

  • 00083208340178 ()

  • Outer Diameter: 4 Millimeter
  • One Piece 4.0mm Diameter x 17mm Length CBA
  • Length: 17 Millimeter
ITO 4.0 x 17mm (CBA)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 4.0mm diameter and 14mm in length crown and bridge angled head
Suncoast Dental, Inc
One Piece/4.0 x 14CBA
In Commercial Distribution

  • 00083208340147 ()

  • Length: 14 Millimeter
  • One Piece 4.0mm Diameter x 14mm Length CBA
  • Outer Diameter: 4 Millimeter
ITO 4.0 x 14mm (CBA)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 17mm in length crown and bridge angled head
Suncoast Dental, Inc
One Piece/3.5 x 17CBA
In Commercial Distribution

  • 00083208335174 ()

  • One Piece 3.5mm Diameter x 17mm Length CBA
  • Length: 17 Millimeter
  • Outer Diameter: 3.5 Millimeter
ITO 3.5 x 17mm (CBA)

  • Screw endosteal dental implant, one-piece
One Piece Dental Implant 3.5mm diameter and 14mm in length crown and bridge angled head
Suncoast Dental, Inc
One Piece/3.5 x 14CBA
In Commercial Distribution

  • 00083208335143 ()

  • Length: 14 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • One Piece 3.5mm Diameter x 14mm Length CBA
ITO 3.5 x 14mm (CBA)

  • Screw endosteal dental implant, one-piece
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