FDA UDI
In Commercial Distribution
🇺🇸 United States
RapidSorb
DI: 10887587064239
·
Model: 851.801.01S
·
Synthes GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- RapidSorb
- Primary DI
- 10887587064239
- Version / Model
- 851.801.01S
- Catalog Number
- 85180101S
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- 7963d9d9-35cb-4c0d-91c6-6ff3e485f3ae
Device Description
RAPID RESORBABLE CRANIAL CLAMP 18MM
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 |
|---|---|---|---|---|
| GXR | COVER, BURR HOLE | Neurology | 882.5250 | 2 |
| HBW | FASTENER, PLATE, CRANIOPLASTY | Neurology | 882.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46639 | Craniofacial bone tack, bioabsorbable | A small, bioabsorbable, cylindrical shaft, typically with a flat, rounded head at one end and tapered to a point at the other, intended to be implanted into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures (e.g., dental regeneration membrane fixation), or to maintain the relative position of bony fragments, bone grafts, or bone graft substitutes. It is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., a degradable polymer), and may be designed to be heated during implantation, with a dedicated inserter, to facilitate its moulding and optimal insertion. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H98085180101S0 | HIBCC | ||||
| Primary | 10887587064239 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041611 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- .
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- High: 43 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- High: 110 Degrees Fahrenheit