FDA UDI In Commercial Distribution 🇺🇸 United States

PDT, Inc.

DI: 00813677021588 · Model: R292 Ward 1 · PDT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PDT, Inc.
Primary DI
00813677021588
Version / Model
R292 Ward 1
Catalog Number
R292
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
2
Public Version Date
2022-05-17
Public Version Status
Update
Public Device Record Key
5dd1ad2a-ed82-4960-93ac-92d5c71913f9

Device Description

Ward 1

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
EKH Carver, Dental Amalgam, Operative

GMDN Terms

Code Name
35793 Dental restoration carver, amalgam, reusable

Identifiers

Type ID
Primary 00813677021588