← Back to catalogue

Duet®

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
Duet® FDA UDI
Generic Name
Cerebrospinal fluid external drainage kit FDA UDI
Device Name
EDMS DUET 46914 SMARTSITE SITES FDA UDI
Model / Reference
46914 FDA UDI
Description
EDMS DUET 46914 SMARTSITE SITES FDA UDI

Identifiers

Primary DI / UDI-DI
00763000428754 FDA UDI
510(k) Number
DEN120017 FDA UDI
FDA Product Code
PCB FDA UDI
JXG FDA UDI
GWM FDA UDI
GMDN Term
Cerebrospinal fluid external drainage kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5560 FDA UDI
882.5550 FDA UDI
882.1620 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

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

Cleared under the same submission

DEN120017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic PS Medical

Sources (1)

  • FDA UDI c9ef700c-248b-4c12-befd-9bfc5aad86ce 36 fields · synced May 31, 2026