Skip to content

Custom Healthcare Systems B9-17507A

by Manus Medical, LLC

Custom Healthcare Systems B9-17507A is a Class II device made by Manus Medical, LLC, listed in FDA GUDID since 24 Jul 2018 (UDI-DI 00811870032721), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811870032721 UDI-DI Date24 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Custom Healthcare Systems
Generic name
Surgical patient preparation kit
Model / reference
B9-17507A
Primary DI / UDI-DI
00811870032721
FDA product code
LRO
GMDN term
Surgical patient preparation kit
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Surgical patient preparation kit

Other devices from Manus Medical, LLC

See all devices from Manus Medical, LLC →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Convenience kit
  • Combination product
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (6, all answered No)