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Surgical Direct SD 13128

by Surgical Direct, Inc.

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 NumberB382SD131280 UDI-DI Date27 Apr 2020ListedStatusListed 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  • Withdrawn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
Surgical Direct
Generic Name
Endoscope sheath, reusable
Model / Ref / Catalog
SD 13128
Primary DI / UDI-DI
B382SD131280
510(k) Number
FDA Product Code
GCJ
GMDN Term
Endoscope sheath, reusable
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 36 Centimeter
Outer Diameter — 5 Millimeter

Related devices

Category: Endoscope sheath, reusable

Cleared under the same submission (K974382)

Show all (12)

Other devices from Surgical Direct, Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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