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StaClear SC250

by Staclear, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 NumberB994SC2500 UDI-DI Date11 Dec 2020ListedStatusListed GUDID: not 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  • Withdrawn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
StaClear
Generic Name
General-purpose syringe/needle
Model / Ref / Catalog
SC250
Primary DI / UDI-DI
B994SC2500
510(k) Number
FDA Product Code
QLY, FMF, FMI
GMDN Term
General-purpose syringe/needle
Device Class
Class II
Regulation Number
880.5860, 880.5570
GUDID distribution status
Not in Commercial Distribution
Size
Total Volume — 0.25 Milliliter
Needle Gauge — 31 Gauge
Length — 8 Millimeter

Other devices from Staclear, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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