AccessGUDID - DEVICE: coflex Interlaminar Technology, 12mm (04260148898525)

GUDID

Device Identifier (DI) Information

Brand Name: coflex Interlaminar Technology, 12mm
Version or Model: UQI00012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Paradigm Spine, LLC

Primary DI Number: 04260148898525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 787874960 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable	An assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

GMDN Preferred Term Name

GMDN Definition

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable

An assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

FDA Product Code

[?]

Product Code	Product Code Name
NQO	Prosthesis, Spinous Process Spacer/Plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110008	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 841cf76b-31d3-49bc-ab24-d5b0bf598ec1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 28, 2014