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Sklar®

FDA UDI

Class II (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Enzymatic sterilization indicator FDA UDI
Device Name
INDICATOR TAPE STEAM 1/2"X60YD FDA UDI
Model / Reference
10-1130 FDA UDI
Description
INDICATOR TAPE STEAM 1/2"X60YD FDA UDI

Identifiers

Primary DI / UDI-DI
10649111281792 FDA UDI
510(k) Number
K890759 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Enzymatic sterilization indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Enzymatic sterilization indicator

Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enzymatic sterilization indicator.

Cleared under the same submission

K890759 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI 0751df63-21ba-476f-9c78-6b68124bf2dc 34 fields · synced Jun 8, 2026