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C1® Depth Limiter 022012

by LSI Solutions, Inc. 2 variants

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 Number00850012846512 UDI-DI Date8 Dec 2025ListedStatusListed 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  • Withdrawn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
C1® Depth Limiter
Generic Name
Suturing unit depth limiter
Model / Ref / Catalog
022012
Primary DI / UDI-DI
00850012846512
510(k) Number
FDA Product Code
HCF
GMDN Term
Suturing unit depth limiter
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K100593)

Show all (12)

Other devices from LSI Solutions, Inc.

See all devices from LSI Solutions, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Expiration Date
  • Manufacturing 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
  • Lot / Batch Number: No
  • Serial Number: No