FDA UDI Not in Commercial Distribution 🇺🇸 United States

Single Use Aspiration Needle NA-220H/230H

DI: 04953170309175 · Model: NA-220H-8025 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Single Use Aspiration Needle NA-220H/230H
Primary DI
04953170309175
Version / Model
NA-220H-8025
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-07-02
Public Version
3
Public Version Date
2022-06-24
Public Version Status
Update
Public Device Record Key
5c62efaf-163f-4bef-9379-55cc7dd1b36c
Distribution End Date
2022-06-23

Device Description

Single Use Aspiration Needle NA-220H

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
FCG Biopsy needle

GMDN Terms

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

Identifiers

Type ID
Package 14953170309172
Primary 04953170309175

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K023272 000