BioGlide®

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name: BioGlide® FDA UDI
Generic Name: Cerebrospinal fluid shunt valve FDA UDI
Device Name: VALVE 92322 CSF CONT REG LOW BIO FDA UDI
Model / Reference: 92322 FDA UDI
Description: VALVE 92322 CSF CONT REG LOW BIO FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169010215 FDA UDI
510(k) Number: K951258 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Cerebrospinal fluid shunt valve FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cerebrospinal fluid shunt valve

BioGlide® by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cerebrospinal fluid shunt valve.

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CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II

Cleared under the same submission

K951258 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic PS Medical

Sources (1)

FDA UDI 5810b9d7-d6e3-4a3e-ad72-832151837d7f 36 fields · synced May 30, 2026