FDA UDI In Commercial Distribution 🇺🇸 United States

BufferPro

DI: 00348783012699 · Model: 01B0000 · PREMIER DENTAL PRODUCTS COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
BufferPro
Primary DI
00348783012699
Version / Model
01B0000
Catalog Number
9007180
Company Name
PREMIER DENTAL PRODUCTS COMPANY
Labeler DUNS
014789663
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-12-18
Public Version
1
Public Version Date
2024-12-26
Public Version Status
New
Public Device Record Key
e370561f-cbfc-4ce8-9519-7135002a1d2c

Device Description

BufferPro Box of 25 Units

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
JCC Ph Buffer

GMDN Terms

Code Name
42693 pH-adjusted buffer solution IVD

Identifiers

Type ID
Primary 00348783012699