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Carerite®

FDA UDI

Class II (US FDA UDI)

by Stepac L.a. Ltd.

Identity

Trade Name
Carerite® FDA UDI
Generic Name
Sterilization packaging, single-use FDA UDI
Device Name
3" Sterilization Tubing Cont Ind FDA UDI
Model / Reference
1 FDA UDI
Description
3" Sterilization Tubing Cont Ind FDA UDI

Identifiers

Primary DI / UDI-DI
00729001667806 FDA UDI
510(k) Number
K870147 FDA UDI
FDA Product Code
FRG FDA UDI
GMDN Term
Sterilization packaging, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Carerite® by Stepac L.a. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K870147 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stepac L.a. Ltd.

Sources (1)

  • FDA UDI 49ccb3f9-0279-47a8-9fff-7134de81fc7e 35 fields · synced May 30, 2026