AccessGUDID - DEVICE: NA (10888551029209)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: SYN03.311.092
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SYN03.311.092
Company Name: STERILMED, INC.

Primary DI Number: 10888551029209
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: SYNTHES BOLT EYE

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?
46453	External orthopaedic fixation system reprocessed component	A component of an external fixation system intended to be used to stabilize a fractured bone/joint. It may be a specially designed frame, clamp, rod, pin, rod-to-rod coupling, rod-to-pin coupling, post, fastener, wire, bolt, washer, nut, hinge, ring, socket, bar, screw, or other device. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051957	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: b2e66f6e-40de-4d7e-a455-21fcbb47e696
Public Version Date: February 14, 2025
Public Version Number: 7
DI Record Publish Date: September 22, 2015