AccessGUDID - DEVICE: Synicem Hip Spacer Trial Case (marked) XL (15060155712694)

GUDID

Device Identifier (DI) Information

Brand Name: Synicem Hip Spacer Trial Case (marked) XL
Version or Model: 515093
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 515093
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 15060155712694
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: Synicem Hip Spacer Trial Case (marked) XL

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
63525	Hip revision prosthesis trial	A copy of a final hip revision prosthesis, in the form of a combined femoral stem and head, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	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: 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: db66b9ed-c52c-4754-8c33-67d68550bcd1
Public Version Date: July 16, 2025
Public Version Number: 2
DI Record Publish Date: July 08, 2025