FDA UDI
In Commercial Distribution
🇺🇸 United States
RapidSorb
DI: 20887587061815
·
Model: 806.004.02S
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- RapidSorb
- Primary DI
- 20887587061815
- Version / Model
- 806.004.02S
- Catalog Number
- 80600402S
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 7
- Public Version Date
- 2024-11-13
- Public Version Status
- Update
- Public Device Record Key
- d2e92d81-63c8-44bd-b63d-e1b651d83680
Device Description
2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JEY | PLATE, BONE | Dental | 872.4760 | 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 |
|---|---|---|---|---|---|---|
| Secondary | H98080600402S0 | HIBCC | ||||
| Primary | 20887587061815 | GS1 | ||||
| Unit of Use | 80887587061817 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- .
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- High: 110 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- High: 43 Degrees Celsius