FDA UDI In Commercial Distribution 🇺🇸 United States

Plasdent

DI: D83280901 · Model: 8090 · PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50

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Basic Information

Brand Name
Plasdent
Primary DI
D83280901
Version / Model
8090
Catalog Number
8090
Company Name
PLASDENT CORPORATION
Labeler DUNS
190377184
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2022-01-14
Public Version
1
Public Version Date
2022-01-24
Public Version Status
New
Public Device Record Key
e9a17ef5-f0f7-4a81-9d0b-47ca16d01c87

Device Description

Disposable Impression Syringe, 1 1/2" Longer, Bendable Tip

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
No
Sterilization Prior Use
No

Product Codes

Code Name
EID Syringe, Restorative And Impression Material

GMDN Terms

Code Name
35860 Dental impression material syringe, reusable

Identifiers

Type ID
Unit of Use D83280900
Primary D83280901