Identity
- Trade Name
- SandShark Injectable Anchor System FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Device Name
- SandShark Injectable Anchor System FDA UDI
- Model / Reference
- SHRK-ALL-1K-US FDA UDI
- Description
- SandShark Injectable Anchor System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850051034222 FDA UDI
- FDA Product Code
- GZB FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Weight — .25 Gram FDA UDI
SandShark Injectable Anchor System by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stimwave Technologies Incorporated
Sources (1)
- FDA UDI 82e58141-3a2f-4fa8-b306-dde596fdd5bf 35 fields · synced May 31, 2026