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Diversatek Healthcare 1201-116

by Diversatek Healthcare United States GUDID

Product code FCH

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM78312011160 UDI-DIDate14 Nov 2025ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Diversatek Healthcare
Generic Name
Endoscopy preparation kit
Model / Ref / Catalog
1201-116
Primary DI / UDI-DI
M78312011160
FDA Product Code
FCH
GMDN Term
Endoscopy preparation kit
Device Class
Class I
Regulation Number
876.4730
Commercial Distribution
In Commercial Distribution

Other devices from Diversatek Healthcare

See all devices from Diversatek Healthcare →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI c87f6ea0-c4e5-4d03-b04c-3fe2192244de 35 fields · synced 23 Oct 2026