FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 10886982226570
·
Model: 456.115
·
SYNTHES (U.S.A.) LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10886982226570
- Version / Model
- 456.115
- Catalog Number
- 456115
- Company Name
- SYNTHES (U.S.A.) LP
- Labeler DUNS
- 832637081
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 5
- Public Version Date
- 2019-11-18
- Public Version Status
- Update
- Public Device Record Key
- 028ae355-7652-43e3-ae52-a124fa4ffcd6
- Distribution End Date
- 2019-11-17
Device Description
TI SPIRAL BLADE 115MM
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 |
|---|---|---|---|---|
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47788 | Spiral blade | An implantable, rod-like, cannulated device with spiralled flutes at the distal end and a smooth cylindrical portion at the proximal end that is used in combination with a bone fixation plate or an intramedullary nail to support bone fragments after fractures, particularly in the proximal femur or proximal humerus (the bone heads). It is made of metal that cannot be chemically degraded (e.g., surgical steel, titanium alloy). It is intended to decrease the amount of removed bone required for device insertion, and provides a support surface in the zone requiring support (bone head) and resistance to bending in the zone most subject to torque. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H6794561150 | HIBCC | ||||
| Primary | 10886982226570 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K932593 | 000 |