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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Dental/maxillofacial surgical procedure kit, medicated, single-use FDA UDI
Device Name
DENTAL PK SRMH 182424 FDA UDI
Model / Reference
SEN12DTRO4 FDA UDI
Description
DENTAL PK SRMH 182424 FDA UDI

Identifiers

Catalog Number
SEN12DTRO4 FDA UDI
Primary DI / UDI-DI
10195594711917 FDA UDI
FDA Product Code
OFX FDA UDI
GMDN Term
Dental/maxillofacial surgical procedure kit, medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/maxillofacial surgical procedure kit, medicated, single-use

Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental/maxillofacial surgical procedure kit, medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 9114d633-c66e-4fcb-9827-65782645ac85 35 fields · synced Jun 8, 2026