FDA UDI
In Commercial Distribution
🇺🇸 United States
GPC
DI: 08905892055751
·
Model: 765.56T
·
GPC MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GPC
- Primary DI
- 08905892055751
- Version / Model
- 765.56T
- Company Name
- GPC MEDICAL LIMITED
- Labeler DUNS
- 915882579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-10
- Public Version
- 1
- Public Version Date
- 2025-09-18
- Public Version Status
- New
- Public Device Record Key
- 08d9b319-d9e2-4368-8154-b45b0158a6d3
Device Description
fixLOCK Self Tapping Screw 3.5 mm- Titanium
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66496 | Custom-made upper limb fixation plate | An implantable sheet of firm non-bioabsorbable material intended to be attached to a bone(s) in the upper limb (e.g., scapula, radius, carpal bone) for management of malunion/nonunion, following osteotomy and/or for arthrodesis, that is produced with specific characteristics as prescribed by a healthcare provider for a specific patient (custom-made). It is made of implant grade metal or carbon fibre. Instruments intended to facilitate implantation (e.g., models, guides), or plate fixation implants (i.e., bone screws), may be included with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08905892055751 | GS1 |
Customer Contacts
- Phone
- 9205302602
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153716 | 000 |