DEVICE: N/A (04961333241972)

Device Identifier (DI) Information

N/A
68391-ACC
In Commercial Distribution

PENTAX OF AMERICA, INC.
04961333241972
GS1

1
083211284 *Terms of Use
COMPUTER ACCESSORIES
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
36859 Computer terminal
An electronic or electromechanical hardware device designed to enter data into, and display data from, a computer or computing system (e.g., central mainframe computer, laboratory computing system), but is itself without data computing capabilities. It is intended as a human-machine interface, and typically consists of a keyboard, mouse, and a visual display unit (VDU) designed to be stationary on a desk or other work platform.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OUG Medical Device Data System
CLOSE

FDA Premarket Submission

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

Sterilization

No
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
No Device Sizes
CLOSE

Device Record Status

0248184f-d7fe-498c-bf20-031d69f03cbb
April 06, 2018
1
March 06, 2018
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
No Package DIs found
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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE