FDA UDI In Commercial Distribution 🇺🇸 United States

PDT, Inc.

DI: 00813677021137 · Model: R168 Explorer 2 · PDT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PDT, Inc.
Primary DI
00813677021137
Version / Model
R168 Explorer 2
Catalog Number
R168
Company Name
PDT, INC.
Labeler DUNS
125850144
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-30
Public Version
3
Public Version Date
2023-01-20
Public Version Status
Update
Public Device Record Key
33dc9820-3a85-47e5-8600-f973600c3fdf

Device Description

Explorer 2

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
EKB Explorer, Operative

GMDN Terms

Code Name
35812 Dental surgical probe, reusable

Identifiers

Type ID
Primary 00813677021137