FDA UDI
In Commercial Distribution
🇺🇸 United States
Medicon
DI: 04046826531539
·
Model: 68.94.76A
·
Medicon eG. Chirurgiemechaniker-Genossenschaft
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Medicon
- Primary DI
- 04046826531539
- Version / Model
- 68.94.76A
- Catalog Number
- 68.94.76A
- Company Name
- Medicon eG. Chirurgiemechaniker-Genossenschaft
- Labeler DUNS
- 315492330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2026-04-02
- Public Version
- 1
- Public Version Date
- 2026-04-10
- Public Version Status
- New
- Public Device Record Key
- fee5d33c-8b0b-42df-ba0e-f64b9ecdf5a3
Device Description
Ti Mini cross slot screw p/10 2.0x17 grey self-tapp fine thr
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- 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 |
|---|---|---|---|---|
| JEY | PLATE, BONE | Dental | 872.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46638 | Craniofacial bone screw, non-bioabsorbable | A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04046826531256 | GS1 | ||||
| Primary | 04046826531539 | GS1 |
Customer Contacts
- Phone
- +490746220090
- [email protected]