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Royal Tek BP20-Bx

by Surgical Design, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810055256761 UDI-DI Date21 Apr 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  • Withdrawn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
Royal Tek
Generic Name
Skin-coring punch, single-use
Model / Reference
BP20-BX
Primary DI / UDI-DI
00810055256761
FDA Product Code
LRY
GMDN Term
Skin-coring punch, single-use
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution

Other devices from Surgical Design, Inc.

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Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No