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Exacta™

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
Exacta™ FDA UDI
Generic Name
Cerebrospinal fluid external drainage kit FDA UDI
Device Name
EDMS 27785 EXACTA 50ML BC NDLESS INJ FDA UDI
Model / Reference
27785 FDA UDI
Description
EDMS 27785 EXACTA 50ML BC NDLESS INJ FDA UDI

Identifiers

Primary DI / UDI-DI
00763000333607 FDA UDI
510(k) Number
K201118 FDA UDI
FDA Product Code
JXG FDA UDI
GWM FDA UDI
GMDN Term
Cerebrospinal fluid external drainage kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
882.1620 FDA UDI
Commercial Distribution
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

Category: Cerebrospinal fluid external drainage kit

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

Similar devices

Also classified as Cerebrospinal fluid external drainage kit.

Cleared under the same submission

K201118 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 bd86a370-fa98-493f-85b4-df7ae8b93ca9 35 fields · synced May 30, 2026