FDA UDI In Commercial Distribution 🇺🇸 United States

Dam Frame

DI: D701RDF2 · Model: RDF · PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Dam Frame
Primary DI
D701RDF2
Version / Model
RDF
Company Name
PULPDENT CORPORATION
Labeler DUNS
001006089
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-21
Public Version
1
Public Version Date
2021-09-29
Public Version Status
New
Public Device Record Key
9d677231-4194-4ec9-8707-5e1f9e50dbdf

Device Description

Radiolucent Rubber Dam Frame

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
High-level Disinfectant

Product Codes

Code Name
EJE Frame, Rubber Dam

GMDN Terms

Code Name
31849 Rubber dam frame

Identifiers

Type ID
Primary D701RDF2