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HydraLock SA with Border 63770

by Sion Brands LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number01714196637702 UDI-DIDate16 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
HydraLock SA with Border
Generic Name
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Model / Reference
63770
Primary DI / UDI-DI
01714196637702
FDA Product Code
NAC
GMDN Term
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Device Class
Class I
Regulation Number
878.4018
GUDID distribution status
In Commercial Distribution

Other devices from Sion Brands LLC

See all devices from Sion Brands LLC →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No