FDA UDI
In Commercial Distribution
🇺🇸 United States
PlusDrive
DI: 20887587043507
·
Model: 400.472
·
Synthes GmbH
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- PlusDrive
- Primary DI
- 20887587043507
- Version / Model
- 400.472
- Catalog Number
- 400472
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 5
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- d44ba203-ff68-4ab5-9697-06d18f2f2a51
Device Description
1.2MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 12MM
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
- 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 |
|---|---|---|---|---|
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| DZL | SCREW, FIXATION, INTRAOSSEOUS | Dental | 872.4880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47635 | Implantable craniofacial bone distractor | An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20887587043507 | GS1 | ||||
| Unit of Use | 80887587043509 | GS1 | ||||
| Secondary | H9804004720 | HIBCC |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]