FDA UDI
In Commercial Distribution
🇺🇸 United States
DELTA
DI: 37613327598194
·
Model: 75-17125
·
Stryker Leibinger GmbH & Co. KG
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- DELTA
- Primary DI
- 37613327598194
- Version / Model
- 75-17125
- Catalog Number
- 75-17125
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-01-17
- Public Version
- 1
- Public Version Date
- 2025-01-27
- Public Version Status
- New
- Public Device Record Key
- d6078576-664d-448d-a2e9-c6e1f5959635
Device Description
Delta screw 12 PK
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 |
|---|---|---|---|---|
| HRS | Plate, fixation, bone | Orthopedic | 888.3030 | 2 |
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| MAI | Fastener, fixation, biodegradable, soft tissue | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46637 | Craniofacial bone screw, 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 is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07613327598193 | GS1 | ||||
| Primary | 37613327598194 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993061 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5.0 | Millimeter | |
| Device Size Text, specify | Diameter: 1.7 Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 49 Degrees Celsius