FDA UDI In Commercial Distribution 🇺🇸 United States

PDT, Inc.

DI: 00813677024343 · Model: R037 · PDT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PDT, Inc.
Primary DI
00813677024343
Version / Model
R037
Company Name
PDT, INC.
Labeler DUNS
125850144
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-30
Public Version
1
Public Version Date
2023-02-07
Public Version Status
New
Public Device Record Key
5f5bb4e5-5075-41c2-82fe-4bbada1117c7

Device Description

R037 Amazing Gracey™ 1-2 Extended Reach

Device Characteristics

Single Use
No
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
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", "Dry Heat Sterilization"]

Product Codes

Code Name
EMS Curette, Periodontic

GMDN Terms

Code Name
41660 Periodontal curette

Identifiers

Type ID
Primary 00813677024343