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Strata®, BioGlide®

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
Strata®, BioGlide® FDA UDI
Generic Name
Ventriculoperitoneal shunt FDA UDI
Device Name
SHUNT 27822 STRATA II SNP ASSY SM BIO FDA UDI
Model / Reference
27822 FDA UDI
Description
SHUNT 27822 STRATA II SNP ASSY SM BIO FDA UDI

Identifiers

Primary DI / UDI-DI
00643169010468 FDA UDI
510(k) Number
K060681 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Ventriculoperitoneal shunt 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 90.0 Centimeter FDA UDI

Category: Ventriculoperitoneal shunt

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

Similar devices

Also classified as Ventriculoperitoneal shunt.

Cleared under the same submission

K060681 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic PS Medical

Sources (1)

  • FDA UDI 92f5ca9b-f830-4dc7-aeab-215883eacfec 36 fields · synced May 30, 2026