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Dual Dual Dot Label

FDA UDI

Class II (US FDA UDI)

by Spsmedical Supply Corp.

Identity

Trade Name
DUAL DUAL DOT LABEL FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Labels that provide a distinct color change when exposed to the appropriate sterilization process FDA UDI
Model / Reference
DDOT-2000 FDA UDI
Description
Labels that provide a distinct color change when exposed to the appropriate sterilization process FDA UDI

Identifiers

Catalog Number
DDOT-2000 FDA UDI
Primary DI / UDI-DI
10732224750757 FDA UDI
510(k) Number
K890763 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chemical/physical sterilization process indicator

Dual Dual Dot Label by Spsmedical Supply Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Cleared under the same submission

K890763 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spsmedical Supply Corp.

Sources (1)

  • FDA UDI d1e6e579-2e3f-4ecc-b07c-973d1f0f4b1a 37 fields · synced Jun 8, 2026