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Integra 3611-581-2-Ir

by Pmt Corp.

Integra 3611-581-2-Ir 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 00650551006510), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K845036

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00650551006510 UDI-DI Date18 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK845036 Date26 Jun 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K845036 decided 26 Jun 1985 Active
  • FDA GUDID UDI-DI 00650551006510 listed 18 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K845036
  2. Listed FDA GUDID 00650551006510

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Integra
Generic name
Skin-port tissue expander
Model / reference
3611-581-2-IR
Primary DI / UDI-DI
00650551006510
510(k) Number
FDA product code
LCJ
GMDN term
Skin-port tissue expander
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K845036)

and 8 more cleared under K845036

Similar devices

Other devices filed under FDA product code LCJ (Tissue Expander And Accessories).

Other devices from Pmt Corp.

See all devices from Pmt Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)