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Case Medical, Inc

FDA UDI

Class II (US FDA UDI)

by Case Medical Inc

Identity

Trade Name
Case Medical, Inc FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
BIOHAZARD SEAL (1000/PK) FDA UDI
Model / Reference
SCS01BH FDA UDI
Description
BIOHAZARD SEAL (1000/PK) FDA UDI

Identifiers

Catalog Number
SCS01BH FDA UDI
Primary DI / UDI-DI
00653159003691 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Category: Chemical/physical sterilization process indicator

Case Medical, Inc by Case Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Case Medical Inc

Sources (1)

  • FDA UDI 87a26003-e475-46c7-9b96-4eb9b47b8ae9 34 fields · synced Jun 1, 2026