FDA UDI In Commercial Distribution 🇺🇸 United States

Core Forms

DI: D701HCF32 · Model: HCF-3 · PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
64

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Basic Information

Brand Name
Core Forms
Primary DI
D701HCF32
Version / Model
HCF-3
Company Name
PULPDENT CORPORATION
Labeler DUNS
001006089
Distribution Status
In Commercial Distribution
Device Count in Pkg
64
Record Status
Published
Publish Date
2021-09-21
Public Version
2
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
7bd13723-08e9-4948-95f6-cf352abb85ee

Device Description

Box of 64 – large

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
EBL Pin, Retentive And Splinting, And Accessory Instruments

GMDN Terms

Code Name
16730 Dental appliance fabrication material, resin

Identifiers

Type ID
Primary D701HCF32
Unit of Use D701HCF31