FDA UDI
In Commercial Distribution
🇺🇸 United States
METICULY Patient-specific titanium maxillofacial mesh implant
DI: 08859751212123
·
Model: MF-212
·
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
- 08859751212123
- Version / Model
- MF-212
- 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
- 75f1c71f-eeaf-4fbf-a5bf-23a1b2a73c46
Device Description
METICULY Patient-specific titanium maxillofacial mesh implant : Orbital 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 |
|---|---|---|---|---|
| 35677 | Orbital wall/rim prosthesis | An implantable ocular device used to reconstruct the orbital roof, floor, medial and/or lateral walls, and/or rim of the eye socket. It may be constructed of one of a variety of materials, or a combination, including stainless steel, titanium (Ti), titanium alloy, or flexible mesh alloplastics. It is an aspherical orbital volume replacement prosthesis that will typically have a spongy outer surface (e.g., reinforced with surgical mesh) designed to encourage tissue attachment and is intended to be used in conjunction with an artificial eye (not included). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18859751212120 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 08859751212123 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232889 | 000 |