AccessGUDID - DEVICE: TWISTR (10886705026173)

GUDID

Device Identifier (DI) Information

Brand Name: TWISTR
Version or Model: 232301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 232301
Company Name: Medos International Sàrl

Primary DI Number: 10886705026173
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: TWISTR Outside-In ACL Disposables Kit Kit Contains: TWISTR Outside-In Suture Passing Fork, 1.1mm x 15 Inches (38 cm) Nitinol Guidewire, 14 Inches Drill Tip Passing Pin (2.4mm x 35 cm), Malleable Graft Retractor, Marking Pen, Ruler (0-15cm Plus or Minus 0.5mm)

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:	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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64145	Ligament reconstruction instrument set, single-use	A collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDD	Kit, surgical instrument, disposable

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: 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: c8717684-2a2e-4e51-9170-64b216f4001f
Public Version Date: August 30, 2021
Public Version Number: 5
DI Record Publish Date: December 15, 2016