Integra 3611-230-2-St
by Pmt Corp.
Integra 3611-230-2-St is a device classified as Unclassified made by Pmt Corp., cleared under FDA 510(k) K845036 on 26 Jun 1985 and listed in FDA GUDID since 18 May 2026 (UDI-DI 00650551006077), active as of 22 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 | Number00650551006077 | Date18 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK845036 | Date26 Jun 1985 | StatusActive |
Official records
- AccessGUDID record 00650551006077
- FDA 510(k) database K845036
Across registries
- FDA 510(k) K845036 decided 26 Jun 1985 Active
- FDA GUDID UDI-DI 00650551006077 listed 18 May 2026 Listed
Timeline
- Cleared FDA 510(k) K845036
- Listed FDA GUDID 00650551006077
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integra
- Generic name
- Skin-port tissue expander
- Model / reference
- 3611-230-2-ST
- Primary DI / UDI-DI
- 00650551006077
- 510(k) Number
- FDA product code
- LCJ
- GMDN term
- Skin-port tissue expander
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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