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Sterile Sheath for CONVIVO

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name
Sterile Sheath for CONVIVO FDA UDI
Generic Name
Optical medical device procedural cover FDA UDI
Model / Reference
302732-0530-000 FDA UDI

Identifiers

Primary DI / UDI-DI
04049539103413 FDA UDI
510(k) Number
K181116 FDA UDI
K211156 FDA UDI
FDA Product Code
OWN FDA UDI
LLZ FDA UDI
GWG FDA UDI
GMDN Term
Optical medical device procedural cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.2050 FDA UDI
882.1480 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

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

Yes

FDA UDI

Category: Optical medical device procedural cover

Sterile Sheath for CONVIVO by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical medical device procedural cover.

Cleared under the same submission

K181116 also covers:

K211156 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carl Zeiss Meditec AG

Sources (1)

  • FDA UDI 15858337-3164-47ce-8d22-aa62d2403dcc 33 fields · synced May 29, 2026