Skip to content

Integra® Miltex® 30-HDS1

by Integra LifeSciences Production Corporation

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 Number10381780170983 UDI-DI Date26 Aug 2016ListedStatusListed 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  • Withdrawn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
Integra® Miltex®
Generic Name
Pelvic-organ-supporting pessary
Model / Ref / Catalog
30-HDS1
Primary DI / UDI-DI
10381780170983
510(k) Number
FDA Product Code
HHW
GMDN Term
Pelvic-organ-supporting pessary
Device Class
Class II
Regulation Number
884.3575
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Pelvic-organ-supporting pessary

Cleared under the same submission (K013289)

Show all (12)

Other devices from Integra LifeSciences Production Corporation

See all devices from Integra LifeSciences Production Corporation →

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