AccessGUDID - DEVICE: X-Wing Sliding Base (09421028113465)

GUDID

Device Identifier (DI) Information

Brand Name: X-Wing Sliding Base
Version or Model: 72205272
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72205272
Company Name: ENZTEC LIMITED

Primary DI Number: 09421028113465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 592616445 *Terms of Use

Device Description: Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction

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?
44872	Orthopaedic graft tensioner, reusable	A hand-held, manual surgical instrument intended to be used during an open-surgery procedure [e.g., acromioclavicular joint repair, anterior cruciate ligament (ACL) reconstruction] to apply appropriate tension to a ligament graft/prosthesis, or flexible cord, to remove slack and facilitate adequate positioning of the device during implantation; it may also be used to apply tension to flexible instruments used during the procedure (e.g., graft sizer or gauge). Tension is applied to the graft after one end of the graft has been secured. The device is typically made of metal and in the form of a shaft with distal prongs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c25c5a11-0825-4aab-80ea-38fb72f62ce6
Public Version Date: December 09, 2020
Public Version Number: 1
DI Record Publish Date: December 01, 2020