AccessGUDID - DEVICE: LIGAPASS (03613720262282)

GUDID

Device Identifier (DI) Information

Brand Name: LIGAPASS
Version or Model: B19134550S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDICREA INTERNATIONAL

Primary DI Number: 03613720262282
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 383228632 *Terms of Use

Device Description: LigaPASS CONNECTOR FOR Ø4.5 mm ROD

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?
61690	Internal orthopaedic fixation system, cerclage wire/cable, sterile	A sterile assembly of implantable devices designed for general orthopaedic repairs including procedures for long bone fractures, hips, spine, bone grafting and reinforcement of bone. It may also be used for supplementary fixation and reduction with bone plate/screw systems. It typically consists of cerclage wires or cables and crimps and/or clamps made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy). It may also include instruments for the attachment of the implants such as crimping tool, cerclage wire/cable cutting tool, a tensioning tool, and a passer.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OWI	Bone Fixation Cerclage, Sublaminar

FDA Premarket Submission

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

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: b9355932-337f-4404-999d-2c3e37c7e83a
Public Version Date: February 19, 2024
Public Version Number: 7
DI Record Publish Date: January 27, 2017