FDA UDI In Commercial Distribution 🇺🇸 United States

PENTAX Medical

DI: 04961333247462 · Model: OS-A115 · HOYA CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PENTAX Medical
Primary DI
04961333247462
Version / Model
OS-A115
Company Name
HOYA CORPORATION
Labeler DUNS
691519705
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-15
Public Version
2
Public Version Date
2024-02-15
Public Version Status
Update
Public Device Record Key
af0f83bd-de2b-4e3b-bbf5-f20efd886e74

Device Description

PENTAX Medical Keyboard EN OS-A115

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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
FDS Gastroscope And Accessories, Flexible/Rigid
FDF Colonoscope And Accessories, Flexible/Rigid
EOQ Bronchoscope (Flexible Or Rigid)

GMDN Terms

Code Name
62940 Computer/medical device keyboard

Identifiers

Type ID
Primary 04961333247462