AccessGUDID - DEVICE: RELJA Reduction Clamp (Left and Right) (00860005968817)

GUDID

Device Identifier (DI) Information

Brand Name: RELJA Reduction Clamp (Left and Right)
Version or Model: RI-CC-LR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RI-CC-LR
Company Name: Relja Innovations LLC

Primary DI Number: 00860005968817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113596350 *Terms of Use

Device Description: The Relja Innovations Reduction Clamp is a manual surgical instrument intended to position and compress the metatarsal joints during an orthopedic surgery.

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
HWN	Instrument, Compression

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: 417180de-394a-4b7c-a452-ab05930266a5
Public Version Date: January 11, 2024
Public Version Number: 1
DI Record Publish Date: January 03, 2024