FDA UDI In Commercial Distribution 🇺🇸 United States

Accu Trac

DI: D661AT60 · Model: AT6 · COLTENE/WHALEDENT INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Accu Trac
Primary DI
D661AT60
Version / Model
AT6
Company Name
COLTENE/WHALEDENT INC
Labeler DUNS
622185718
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-11-30
Public Version
1
Public Version Date
2018-12-31
Public Version Status
New
Public Device Record Key
7d226fe8-57d4-429d-86bc-24ecf9f3602d

Device Description

Accu-Trac Precision Die System

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
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
61648 Dental prosthesis bite verification device

Identifiers

Type ID
Primary D661AT60