FDA UDI
In Commercial Distribution
🇺🇸 United States
Synicem Hip Spacer Trial Tray XL with Trials
DI: 15060155712113
·
Model: 882023
·
BIOCOMPOSITES LTD
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Synicem Hip Spacer Trial Tray XL with Trials
- Primary DI
- 15060155712113
- Version / Model
- 882023
- Catalog Number
- 882023
- Company Name
- BIOCOMPOSITES LTD
- Labeler DUNS
- 424382307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-08
- Public Version
- 1
- Public Version Date
- 2025-07-16
- Public Version Status
- New
- Public Device Record Key
- 333fd970-ed75-4fc3-b34a-d6ef6048147e
Device Description
Synicem Hip Spacer Trial Tray XL with Trials
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060155712113 | GS1 |
Customer Contacts
- Phone
- +441782338580
- [email protected]