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Camera sleeve

FDA UDI

Class I (US FDA UDI)

by Purple Surgical International Limited

Identity

Trade Name
Camera sleeve FDA UDI
Generic Name
Camera cover, single-use FDA UDI
Device Name
The camera sleeve is used to create a sterile field around the video system camera head and cable. FDA UDI
Model / Reference
PS3901 FDA UDI
Description
The camera sleeve is used to create a sterile field around the video system camera head and cable. FDA UDI

Identifiers

Catalog Number
PS3901 FDA UDI
Primary DI / UDI-DI
15051223029202 FDA UDI
FDA Product Code
KQM FDA UDI
GMDN Term
Camera cover, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4160 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

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

No

FDA UDI

Category: Camera cover, single-use

Camera sleeve by Purple Surgical International Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Camera cover, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Purple Surgical International Limited

Sources (1)

  • FDA UDI 765920e5-4993-45b2-830f-959c21fca7f8 36 fields · synced May 30, 2026