FDA UDI In Commercial Distribution 🇺🇸 United States

Single Use Injector

DI: 04953170422652 · Model: NM-401L-0525 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Single Use Injector
Primary DI
04953170422652
Version / Model
NM-401L-0525
Catalog Number
N6140530
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-16
Public Version
4
Public Version Date
2023-08-30
Public Version Status
Update
Public Device Record Key
2a1fe3e0-72e5-4b68-ae81-129c5961fe19

Device Description

Single Use Injector

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
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FBK endoscopic injection needle, gastroenterology-urology

GMDN Terms

Code Name
38825 General-purpose endoscopic needle, single-use

Identifiers

Type ID
Package 14953170422659
Primary 04953170422652
Package 54953170422657

Customer Contacts