AccessGUDID - DEVICE: RIGIDLOOP (10886705024070)

GUDID

Device Identifier (DI) Information

Brand Name: RIGIDLOOP
Version or Model: 218034
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 218034
Company Name: Medos International Sàrl

Primary DI Number: 10886705024070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: RIGIDLOOP Adjustable Disposables Kit 4.5mm Combo Reamer/Passing Pin (10-160mm Plus or minus 0.1mm), 1.1mm x 15 Inches (38 cm) Nitinol Guidewire, 14 Inches Drill Tip Passing Pin (2.4mm x 35cm), Threaded Tibial Cannula, Malleable Graft Retractor, Marking Pen, Ruler (0-15cm Plus or minus 0.5m)

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?
44052	Orthopaedic surgical procedure kit, non-medicated, single-use	A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use 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: 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: 3d2a7b4f-7b04-47b4-b996-c98a8376f398
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2015