FDA UDI
In Commercial Distribution
🇺🇸 United States
DELTA
DI: 07613153066828
·
Model: 70-05350
·
Stryker Leibinger GmbH & Co. KG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DELTA
- Primary DI
- 07613153066828
- Version / Model
- 70-05350
- Catalog Number
- 70-05350
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 8
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 82e22df9-b21e-4178-8204-46c31f977108
Device Description
DELTA 1.7MM MESH 122X122X0.75MM
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
- MR Safe
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | Orthopedic | 888.3030 | 2 |
| JEY | PLATE, BONE | Dental | 872.4760 | 2 |
| HBW | FASTENER, PLATE, CRANIOPLASTY | Neurology | 882.5360 | 2 |
| GXR | COVER, BURR HOLE | Neurology | 882.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46641 | Craniofacial fixation plate, bioabsorbable | 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, and/or cover a burr hole. It is made of bioabsorbable materials (e.g., degradable polymer) 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 bioabsorbable 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 | 07613153066828 | GS1 |
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 122.0 | Millimeter | |
| Device Size Text, specify | Thickness: 0.75 Millimeter | ||
| Length | 122.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 49 Degrees Celsius