FDA UDI
In Commercial Distribution
🇺🇸 United States
METICULY Patient-specific titanium maxillofacial mesh implant
DI: 08859751213113
·
Model: MF-311
·
METICULY COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- METICULY Patient-specific titanium maxillofacial mesh implant
- Primary DI
- 08859751213113
- Version / Model
- MF-311
- Company Name
- METICULY COMPANY LIMITED
- Labeler DUNS
- 661695214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-31
- Public Version
- 3
- Public Version Date
- 2026-03-09
- Public Version Status
- Update
- Public Device Record Key
- 6b92c02b-6c01-42ae-950c-7cc0342f81d7
Device Description
METICULY Patient-specific titanium maxillofacial mesh implant : Facial Mesh S non-sterile
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| JEY | Plate, Bone | Dental | 872.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46642 | Craniofacial fixation plate, non-bioabsorbable, non-customized | A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18859751213110 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 08859751213113 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232889 | 000 |