FDA UDI In Commercial Distribution 🇺🇸 United States

Roydent Absortbent paper Points Zipperer

DI: D8090560080Z1 · Model: 0560080Z · ROYDENT DENTAL PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
180

Basic Information

Brand Name
Roydent Absortbent paper Points Zipperer
Primary DI
D8090560080Z1
Version / Model
0560080Z
Catalog Number
0560080Z
Company Name
ROYDENT DENTAL PRODUCTS INC
Labeler DUNS
131487225
Distribution Status
In Commercial Distribution
Device Count in Pkg
180
Record Status
Published
Publish Date
2022-10-26
Public Version
1
Public Version Date
2022-11-03
Public Version Status
New
Public Device Record Key
239df7da-073f-4efd-b74d-95ff1863cc44

Device Description

Absorbent Points (standard/sterile)

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
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
EKN POINT, PAPER, ENDODONTIC

GMDN Terms

Code Name
38777 Endodontic paper point

Identifiers

Type ID
Unit of Use D8090560080Z0
Primary D8090560080Z1