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HEINE UniSpec® Disposable Tubes

FDA UDI

Class II (US FDA UDI)

by Heine Optotechnik GmbH & Co. KG

Identity

Trade Name
HEINE UniSpec® Disposable Tubes FDA UDI
Generic Name
Optical proctoscope, single-use FDA UDI
Model / Reference
000 FDA UDI

Identifiers

Catalog Number
E-003.19.811 FDA UDI
Primary DI / UDI-DI
04053755126774 FDA UDI
FDA Product Code
GCM FDA UDI
GMDN Term
Optical proctoscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Optical proctoscope, single-use

HEINE UniSpec® Disposable Tubes by Heine Optotechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical proctoscope, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heine Optotechnik GmbH & Co. KG

Sources (1)

  • FDA UDI 3b36d71b-52e0-428e-afd2-9b855a6db090 34 fields · synced May 30, 2026