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ComforTen® 60-hole covered tray 8000001372

by Jubilant Hollisterstier LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00365044000080 UDI-DI Date2 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ComforTen® 60-hole covered tray
Generic Name
Allergy testing lancet
Model / Ref / Catalog
8000001372
Primary DI / UDI-DI
00365044000080
510(k) Number
FDA Product Code
LDG
GMDN Term
Allergy testing lancet
Device Class
Class I
Regulation Number
874.3300
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K953939)

Other devices from Jubilant Hollisterstier LLC

See all devices from Jubilant Hollisterstier LLC →

Properties

  • Prescription Use
  • Combination Product
  • Lot / Batch Number

Other properties (11)

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