Apogee Plus B18F

by Hollister Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number20610075177435 UDI-DI	Date21 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Apogee Plus
Generic Name: Single-administration urethral drainage catheter
Model / Reference: B18F

Primary DI / UDI-DI: 20610075177435
510(k) Number: K032710
FDA Product Code: KOD
GMDN Term: Single-administration urethral drainage catheter

Device Class: Class II
Regulation Number: 876.5130
GUDID distribution status: In Commercial Distribution

Size: Catheter Gauge — 18 French
Length — 16 Inch

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Properties

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