FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 04961333241842 · Model: 1111-1977 · PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
N/A
Primary DI
04961333241842
Version / Model
1111-1977
Company Name
PENTAX OF AMERICA, INC.
Labeler DUNS
083211284
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-06
Public Version
1
Public Version Date
2018-04-06
Public Version Status
New
Public Device Record Key
7728caf6-1d7b-4a4b-8f84-f4bafe260d8c

Device Description

DVD-RW DRIVE, EXTERNAL USB

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OUG Medical Device Data System

GMDN Terms

Code Name
45908 DVD recorder

Identifiers

Type ID
Primary 04961333241842