Cannula Standard
by Alpha Omega Engineering Corp. 30 variants
Cannula Standard (STR-008221-00) is a Class II device made by Alpha Omega Engineering Corp., cleared under FDA 510(k) K120098 on 12 Jun 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290014954663), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290014954663 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120098 | Date12 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 07290014954663
- FDA 510(k) database K120098
Across registries
- FDA 510(k) K120098 decided 12 Jun 2012 Active
- FDA GUDID UDI-DI 07290014954663 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120098
- Listed FDA GUDID 07290014954663
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cannula
- Generic name
- Intracerebral cannula, implantable
- Model / Ref / Catalog
- Standard, STR-008221-00
- Primary DI / UDI-DI
- 07290014954663
- 510(k) Number
- FDA product code
- GZL
- GMDN term
- Intracerebral cannula, implantable
- Device class
- Class II
- Regulation number
- 882.1330
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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