FDA UDI In Commercial Distribution 🇺🇸 United States

Premium Plus

DI: D838018OS2 · Model: 018OS · Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
250

Basic Information

Brand Name
Premium Plus
Primary DI
D838018OS2
Version / Model
018OS
Company Name
Premium Plus International Limited
Labeler DUNS
668367758
Distribution Status
In Commercial Distribution
Device Count in Pkg
250
Record Status
Published
Publish Date
2019-12-27
Public Version
1
Public Version Date
2020-01-06
Public Version Status
New
Public Device Record Key
95905c8e-4ab6-4d8b-b5a0-431902f8280e

Device Description

SYRINGE TIPS

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NRD Unit, Operative Dental, Accessories

GMDN Terms

Code Name
18033 Surgical mist irrigation tip

Identifiers

Type ID
Package D838018OS8
Package D838018OS6
Primary D838018OS2
Unit of Use D838018OS0