FDA UDI In Commercial Distribution 🇺🇸 United States

SINGLE USE DISTAL COVER MAJ-2315

DI: 04953170441271 · Model: MAJ-2315 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
SINGLE USE DISTAL COVER MAJ-2315
Primary DI
04953170441271
Version / Model
MAJ-2315
Catalog Number
N6192000
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-01
Public Version
4
Public Version Date
2023-09-20
Public Version Status
Update
Public Device Record Key
5bdee026-6644-4995-b789-fd9492bfb7f1

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FEB Accessories, Cleaning, For Endoscope
FDT Duodenoscope And Accessories, Flexible/Rigid
NWB Endoscope, Accessories, Narrow Band Spectrum

GMDN Terms

Code Name
64277 Endoscope patient protection cap, single-use

Identifiers

Type ID
Package 14953170441278
Primary 04953170441271
Package 54953170441276