DEVICE: N/A (04961333241842)

Device Identifier (DI) Information

N/A
1111-1977
In Commercial Distribution

PENTAX OF AMERICA, INC.
04961333241842
GS1

1
083211284 *Terms of Use
DVD-RW DRIVE, EXTERNAL USB
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?
45908 DVD recorder
A mains electricity (AC-powered), electronic device designed to receive and store both image and sound (i.e., audio, video, or computer data, e.g., motion film) on an optical digital video disc (DVD) as electronic signals. This is a general-purpose recording and playback device; it may also be known as a DVD player.
Obsolete 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

7728caf6-1d7b-4a4b-8f84-f4bafe260d8c
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