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Dualx Dual Portal Disposable Kit-80mm (USA) 12535574080

by Amplify Surgical

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB707125355740800 UDI-DI Date5 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dualx Dual Portal Disposable Kit-80mm (USA)
Generic Name
Surgical retractor/retraction system blade, single-use
Model / Reference
12535574080
Description
INCLUDES: CANNULA 80MM HEMOSTATIC AGENT DELIVERY TUBE
Primary DI / UDI-DI
B707125355740800
510(k) Number
FDA Product Code
MAX
GMDN Term
Surgical retractor/retraction system blade, single-use
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K181397)

Show all (12)

Other devices from Amplify Surgical

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No