ENNOVATE
- Primary DI
- 04046964990601
- Brand
- ENNOVATE
- Company
- Aesculap AG
- Model
- SY931TS
- Catalog number
- SY931TS
- Device description
- ENNOVATE MIS CURVED ROD 5.5X35MM
- Published
- 2018-08-03
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
aesculap.com
bbraun.comProduct Codes
| Code | Name |
|---|---|
| NKB | Thoracolumbosacral pedicle screw system |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04046964990601 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04046964990601 | 04046964990601 | 4046964990601 |
GMDN Terms
| Term | Definition |
|---|---|
| Bone-screw internal spinal fixation system rod | An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(888)229-3002 | setworld_orders@aesculap.com |
| +1(800)282-9000 | GUDID.BBMUS_Service@bbraun.com |
Regulatory Flags
- DUNS number
- 315018218
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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