AccessGUDID - DEVICE: Synicem 48H Shoulder Trial FDA (15060155712403)

GUDID

Device Identifier (DI) Information

Brand Name: Synicem 48H Shoulder Trial FDA
Version or Model: 885423
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 885423
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 15060155712403
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: Reusable Shoulder Trial Spacer allows for the selection of the correct shoulder spacer to avoid manipulation prior to implantation during a 2-step revision shoulder arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “shoulder Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.

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):	Yes
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?
63526	Shoulder revision prosthesis trial	A copy of a final shoulder revision prosthesis, in the form of a combined humeral 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c4bab8fa-064d-44d5-8abd-51bcc1f153a3
Public Version Date: July 16, 2025
Public Version Number: 1
DI Record Publish Date: July 08, 2025