FDA UDI In Commercial Distribution 🇺🇸 United States

Pressure Syringe

DI: D701PSO2 · Model: PS-O · PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Pressure Syringe
Primary DI
D701PSO2
Version / Model
PS-O
Company Name
PULPDENT CORPORATION
Labeler DUNS
001006089
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-23
Public Version
1
Public Version Date
2021-10-01
Public Version Status
New
Public Device Record Key
0a1f591e-2230-46cb-832c-20a985df8192

Device Description

Pressure syringe with handle

Device Characteristics

Single Use
No
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
EID Syringe, Restorative And Impression Material

GMDN Terms

Code Name
17890 Endodontic filling material condenser

Identifiers

Type ID
Primary D701PSO2