AccessGUDID - DEVICE: Tenzor Radiolucent Carbon Fiber Spine Positioning Frame (00810105030297)

GUDID

Device Identifier (DI) Information

Brand Name: Tenzor Radiolucent Carbon Fiber Spine Positioning Frame
Version or Model: 4-0009-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPOSITE MANUFACTURING, INC.

Primary DI Number: 00810105030297
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947090650 *Terms of Use

Device Description: Radiolucent Spine positioning traction frame. Arcing flexures are used to arc the patients spine while in the prone position to expose the spine for surgical procedures.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46762	Traction table, manual	A mobile, manually-operated, table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a mechanical altering of the table surface geometry. The surface typically consists of sections that can be raised and lowered to manipulate the curvature of the patient?s spine whilst he/she lies in a supine position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is typically used in a healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWN	Table And Attachments, Operating-Room

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: bd6c9ad7-3c3e-4fb5-8a2e-1878919db0f6
Public Version Date: March 25, 2024
Public Version Number: 2
DI Record Publish Date: February 14, 2020