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Cardinal Health

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Obstetrical/gynaecological surgical procedure kit, medicated FDA UDI
Device Name
BPS PCK FDA UDI
Model / Reference
SMA4ABPJHK FDA UDI
Description
BPS PCK FDA UDI

Identifiers

Catalog Number
SMA4ABPJHK FDA UDI
Primary DI / UDI-DI
10888439974478 FDA UDI
FDA Product Code
OJF FDA UDI
GMDN Term
Obstetrical/gynaecological surgical procedure kit, medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 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: Obstetrical/gynaecological surgical procedure kit, medicated

Cardinal Health's Hysterectomy Kit is a single-use, sterile surgical instrument and dressing kit designed for obstetrical/gynecological surgery. The device is labeled as a general-purpose surgical kit and does not contain MRI safety information.

Similar devices

Also classified as Obstetrical/gynaecological surgical procedure kit, medicated.

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 71bce340-9f92-4613-9437-d2782bcb68e0 35 fields · synced Oct 6, 2026