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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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Streamline TL Spinal Fixation System - 00191083023755

REDUCTION SCREW
Pioneer Surgical Technology, Inc.
01-RS-95-100
Not in Commercial Distribution

01-RS-95-100

  • Spinal bone screw, non-bioabsorbable

Streamline TL Spinal Fixation System - 00191083023748

REDUCTION SCREW
Pioneer Surgical Technology, Inc.
01-RS-85-95
Not in Commercial Distribution

01-RS-85-95

  • Spinal bone screw, non-bioabsorbable

Sphero Attachments - 00842092122938

Sphero Block Abutment Calcitek Integral SD 3.25 x 2mm (2.5mm Ball)
Preat Corporation
0819613
In Commercial Distribution

0819613

  • Dental implant suprastructure, permanent, preformed

Sphero Attachments - 00842092124406

Sphero Block Abutment TSV 3.5mm x 0mm (1.8mm Ball)
Preat Corporation
0819650
In Commercial Distribution

0819650

  • Dental implant suprastructure, permanent, preformed

Preat Implant Prosthetics - 00842092107768

O-Ring Metal Retainer #4
Preat Corporation
1500204
In Commercial Distribution

1500204

  • Resilient dental precision attachment

obelisc™ vertebral body replacement - 04052536198818

Shaft flexible for screwdriver, hex 3.5 mm
Ulrich GmbH & Co. KG
CS 2932-3
In Commercial Distribution

CS 2932-3

  • General internal orthopaedic fixation system implantation kit

obelisc™ vertebral body replacement - 04052536198795

Locking rod flexible, length 450 mm
Ulrich GmbH & Co. KG
CS 2931-12
In Commercial Distribution

CS 2931-12

  • General internal orthopaedic fixation system implantation kit

obelisc™ vertebral body replacement - 04052536198788

Expansion rod flexible, length 450 mm
Ulrich GmbH & Co. KG
CS 2931-11
In Commercial Distribution

CS 2931-11

  • General internal orthopaedic fixation system implantation kit

obelisc™ vertebral body replacement - 04052536198771

Holder curved, length 450 mm
Ulrich GmbH & Co. KG
CS 2931-10
In Commercial Distribution

CS 2931-10

  • General internal orthopaedic fixation system implantation kit

obelisc™ vertebral body replacement - 04052536198764

obelisc lateral end piece, blue, length 55 mm, angle 15°
Ulrich GmbH & Co. KG
CS 2916-15
In Commercial Distribution

CS 2916-15

  • Vertebral body prosthesis
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