FDA UDI In Commercial Distribution 🇺🇸 United States

Premium Plus

DI: D838780SW2 · Model: 780S-W · Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
Premium Plus
Primary DI
D838780SW2
Version / Model
780S-W
Company Name
Premium Plus International Limited
Labeler DUNS
668367758
Distribution Status
In Commercial Distribution
Device Count in Pkg
500
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
7acaab65-9b03-4e6d-9198-116169e73789

Device Description

NON-WOVEN HEADREST

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
KHR Absorber, Saliva, Paper

GMDN Terms

Code Name
33531 Saliva absorbent

Identifiers

Type ID
Primary D838780SW2
Unit of Use D838780SW0