FDA UDI In Commercial Distribution 🇺🇸 United States

Pac-Dent

DI: 10815967020728 · Model: PPE-248-2 · PAC-DENT INTERNATIONAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Pac-Dent
Primary DI
10815967020728
Version / Model
PPE-248-2
Company Name
PAC-DENT INTERNATIONAL INC
Labeler DUNS
959077454
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2016-08-26
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
b03516f9-4259-4f80-923f-4af8da3933f7

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
No
PM Exempt
No
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
PEM Dental Barriers And Sleeves

GMDN Terms

Code Name
61050 Dental bib

Identifiers

Type ID
Primary 10815967020728
Unit of Use 00815967020721