FDA UDI In Commercial Distribution 🇺🇸 United States

Biopsy valve

DI: 04953170438165 · Model: MB-358 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
Biopsy valve
Primary DI
04953170438165
Version / Model
MB-358
Catalog Number
N6177501
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2023-04-22
Public Version
2
Public Version Date
2023-12-28
Public Version Status
Update
Public Device Record Key
93bde79d-2930-4eba-b313-e04a97e84a18

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
Yes
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
Yes
Sterilization Methods
["High-level Disinfectant", "Ethylene Oxide"]

Product Codes

Code Name
FDS Gastroscope And Accessories, Flexible/Rigid
FDF Colonoscope And Accessories, Flexible/Rigid
NWB Endoscope, Accessories, Narrow Band Spectrum

GMDN Terms

Code Name
64366 Endoscopic biopsy valve, reusable

Identifiers

Type ID
Unit of Use 84953170063943
Primary 04953170438165

Customer Contacts