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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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Rocker, One Piece
Kalitec Direct LLC
15-K01-3110
In Commercial Distribution

  • B07315K0131100 ()
15-K01-3110

  • Orthopaedic rod reducer
Rocker, One Piece
Kalitec Direct LLC
11-K01-3007
In Commercial Distribution

  • B07311K0130070 ()


  • Orthopaedic rod reducer
AIRFLOW One unit
E.M.S. Electro Medical Systems S.A.
FT-230/A
In Commercial Distribution

  • 07613353187392 ()


  • Dental abrasive air jet system
AIRFLOW One basic
E.M.S. Electro Medical Systems S.A.
FT-230W/A
In Commercial Distribution

  • 07613353161965 ()


  • Dental abrasive air jet system
ONE HANDED PERSUADER
Stryker Corporation
48237015
In Commercial Distribution

  • 07613327265637 ()
48237015

  • Orthopaedic rod reducer
Apyx One Console
APYX MEDICAL CORPORATION
APYX-ONE
In Commercial Distribution

  • 00607151050221 ()
APYX-ONE

  • Electrosurgical system generator
one size Black
Darco (Europe) GmbH
BASAB-2
In Commercial Distribution

  • 20609271733255 ()
  • 00609271733251 ()
  • 10609271733258 ()
BASAB-2

  • Ankle/foot orthosis
One Step K-Wire
BK MEDITECH CO.,LTD.
14318-40
In Commercial Distribution

  • 08809763492280 ()


  • Spinal guidewire
One Step K-Wire
BK MEDITECH CO.,LTD.
14318-30
In Commercial Distribution

  • 08809763492273 ()


  • Spinal guidewire
Bridge, one way
OLYMPUS Winter & Ibe GmbH
A20976A
In Commercial Distribution

  • 04042761020398 ()
A20976A

  • Endoscope assembly adaptor
ONE STEP POSITIONER
AADCO MEDICAL, INC.
N-529
In Commercial Distribution

  • 00840348526400 ()
N-529

  • Radiological general body-part positioner
One Way Cushion
Samarit Medical Industries Inc
5260
In Commercial Distribution

  • 00628176153209 ()


  • Wheelchair seat cushion
ONE LEGACY - LA1
MEDLINE INDUSTRIES, INC.
DYNJ64707
In Commercial Distribution

  • 40193489215077 ()
  • 10193489215076 ()
DYNJ64707

  • General surgical procedure kit, non-medicated, single-use
One Step Connector
THOMPSON SURGICAL INSTRUMENTS, INC.
42163
Not in Commercial Distribution

  • 00841536108521 ()


  • Self-retaining surgical retractor, reusable
ONE HOLE STAPLE
Stryker Corporation
48220104
Not in Commercial Distribution

  • 04546540218896 ()
48220104

  • Orthopaedic bone staple, non-adjustable
ONE LEGACY - LA1
MEDLINE INDUSTRIES, INC.
DYNJ64707A
In Commercial Distribution

  • 40195327316328 ()
  • 10195327316327 ()
DYNJ64707A

  • General surgical procedure kit, non-medicated, single-use
One Arm Bolero
Gottfried Medical, Inc.
441
In Commercial Distribution

  • G420441 ()
441

  • Compression/pressure shirt/pants
Rampart One Inserter
SPINEOLOGY INC.
49-28-01
In Commercial Distribution

  • M7404901823 ()
490-1823

  • Polymeric spinal fusion cage, sterile
Rampart One Inserter
SPINEOLOGY INC.
49-10-40
In Commercial Distribution

  • M7404900011 ()
490-0011

  • Polymeric spinal fusion cage, sterile
Non-Cannulated Dilator One
SPINEOLOGY INC.
33-08-03
In Commercial Distribution

  • M7403120013 ()
312-0013

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Rampart One Screw
SPINEOLOGY INC.
10-10-75-8
In Commercial Distribution

  • M7404905030 ()

  • Length: 30 Millimeter
490-5030

  • Polymeric spinal fusion cage, sterile
Rampart One Screw
SPINEOLOGY INC.
10-10-75-7
In Commercial Distribution

  • M7404905025 ()

  • Length: 25 Millimeter
490-5025

  • Polymeric spinal fusion cage, sterile
Rampart One Screw
SPINEOLOGY INC.
10-10-75-6
In Commercial Distribution

  • M7404905020 ()

  • Length: 20 Millimeter
490-5020

  • Polymeric spinal fusion cage, sterile
Rampart One Screw
SPINEOLOGY INC.
10-10-75-5
In Commercial Distribution

  • M7404905015 ()

  • Length: 15 Millimeter
490-5015

  • Polymeric spinal fusion cage, sterile
Rampart One Screw
SPINEOLOGY INC.
10-10-75-4
In Commercial Distribution

  • M7404904530 ()

  • Length: 30 Millimeter
490-4530

  • Polymeric spinal fusion cage, sterile
Rampart One Screw
SPINEOLOGY INC.
10-10-75-3
In Commercial Distribution

  • M7404904525 ()

  • Length: 25 Millimeter
490-4525

  • Polymeric spinal fusion cage, sterile
Rampart One Screw
SPINEOLOGY INC.
10-10-75-2
In Commercial Distribution

  • M7404904520 ()

  • Length: 20 Millimeter
490-4520

  • Polymeric spinal fusion cage, sterile
Rampart One Screw
SPINEOLOGY INC.
10-10-75-1
In Commercial Distribution

  • M7404904515 ()

  • Length: 15 Millimeter
490-4515

  • Polymeric spinal fusion cage, sterile
ONE LEGACY - LA1
MEDLINE INDUSTRIES, INC.
DYNJ64707B
In Commercial Distribution

  • 40198459141486 ()
  • 10198459141485 ()
DYNJ64707B

  • General surgical procedure kit, non-medicated, single-use
One Piece Analog
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118143901 ()
PP1-0002

  • Dental implant system
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