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isolate

FDA UDI

Class I (US FDA UDI)

by Endo/Tech

Identity

Trade Name
isolate FDA UDI
Generic Name
Rubber dam, non-latex FDA UDI
Device Name
isolate Non Latex Dental Dam in Medium Blue. Each sheet measures 5x5 and is manufactured from Polyisoprene. FDA UDI
Model / Reference
i5NLMB FDA UDI
Description
isolate Non Latex Dental Dam in Medium Blue. Each sheet measures 5x5 and is manufactured from Polyisoprene. FDA UDI

Identifiers

Catalog Number
i5NLMB FDA UDI
Primary DI / UDI-DI
D052I5NLMB1 FDA UDI
FDA Product Code
EIE FDA UDI
GMDN Term
Rubber dam, non-latex FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6300 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

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: Rubber dam, non-latex

isolate by Endo/Tech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rubber dam, non-latex.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endo/Tech

Sources (1)

  • FDA UDI 3eecfc53-b5d3-4c33-af2a-188919ec5ea3 34 fields · synced May 30, 2026