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Salivary Access Dilator Set SDDS-18-20-HC

by C2DX, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00850007350338 UDI-DI Date10 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Salivary Access Dilator Set
Generic Name
Salivary gland dilator, single-use
Model / Reference
SDDS-18-20-HC
Primary DI / UDI-DI
00850007350338
FDA Product Code
GCC
GMDN Term
Salivary gland dilator, single-use
Device Class
Class I
Regulation Number
878.4200
GUDID distribution status
In Commercial Distribution

Other devices from C2DX, Inc.

See all devices from C2DX, Inc. →

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