DEVICE: Camera sleeve (15051223029202)

Device Identifier (DI) Information

Camera sleeve
PS3901
In Commercial Distribution
PS3901
PURPLE SURGICAL INTERNATIONAL LIMITED
15051223029202
GS1

1
239403863 *Terms of Use
The camera sleeve is used to create a sterile field around the video system camera head and cable.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37450 Camera cover, single-use
A sterile device made of a material, typically of plastic and shaped to fit the camera, which is used as a physical barrier on a camera to protect it from environmental exposure and/or allow the camera to be used in a sterile surgical field. This is a single-use device.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KQM Camera, Surgical And Accessories
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 2.5m long x 100mm diameter
CLOSE

Device Record Status

765920e5-4993-45b2-830f-959c21fca7f8
March 29, 2018
2
November 16, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
35051223029206 20 15051223029202 In Commercial Distribution
55051223029200 80 35051223029206 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+441923839333
mail@purplesurgical.com
CLOSE