FDA UDI
In Commercial Distribution
🇺🇸 United States
SDS Growing Rod
DI: 08720629951256
·
Model: SDS Growing Rod
·
Baat Medical Products B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SDS Growing Rod
- Primary DI
- 08720629951256
- Version / Model
- SDS Growing Rod
- Catalog Number
- SDS55ROD
- Company Name
- Baat Medical Products B.V.
- Labeler DUNS
- 413205480
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-30
- Public Version
- 2
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- 7e3f796a-949a-4718-a56a-e367442f2a78
Device Description
CoCr rod 5.5mm x 500mm
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 |
|---|---|---|---|---|
| PGM | Growing Rod System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67286 | Spinal rachet-distraction rod | An implantable, mechanical (non-electric, non-magnetic), metallic rod, capable of adjusting in length, designed to be fixed alongside the spinal column enabling periodic lengthening to distract the spine and provide adequate bracing during growth to minimize the progression of scoliosis. It incorporates a rachet-based mechanism that allows noninvasive, post-implantation lengthening during patient growth and/or correction of scoliosis (i.e., self-lengthens in situ). It is fixed to the vertebrae using two pedicle bone screws at its ends, which may be included with the rod. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720629951256 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251961 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The products shall be stored and handled with care. The primary and secondary packaging shall remain intact at all times. The products shall be stored and handled in an environment that is: • dry an