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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
STERILE D C HYSTEROSCOPY PACK FDA UDI
Model / Reference
SMA13DCFHB FDA UDI
Description
STERILE D C HYSTEROSCOPY PACK FDA UDI

Identifiers

Catalog Number
SMA13DCFHB FDA UDI
Primary DI / UDI-DI
10887488109008 FDA UDI
FDA Product Code
OHD FDA UDI
GMDN Term
Obstetrical/gynaecological surgical procedure kit, medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1720 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 Sterile D C Hysteroscopy Pack is a comprehensive obstetrical/gynaecological surgical kit designed for general-purpose procedures, providing sterile and single-use instruments, dressings, and pharmaceuticals. This device meets the regulatory requirements of the Medical Device Industry Association (MDIA) and is suitable for use in hospitals and clinics worldwide.

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 3aac0f59-8d97-4ef6-bfdb-c9da6d556e28 34 fields · synced Jul 22, 2026