FDA UDI In Commercial Distribution 🇺🇸 United States

TMS

DI: D661T1071 · Model: T107 · COLTENE/WHALEDENT INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
22

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Basic Information

Brand Name
TMS
Primary DI
D661T1071
Version / Model
T107
Company Name
COLTENE/WHALEDENT INC
Labeler DUNS
622185718
Distribution Status
In Commercial Distribution
Device Count in Pkg
22
Record Status
Published
Publish Date
2019-02-11
Public Version
2
Public Version Date
2019-10-23
Public Version Status
Update
Public Device Record Key
f8493872-cda7-4418-8c02-dc9c5ef9d704

Device Description

MINIKIN Complete Kit

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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
EBL Pin, Retentive And Splinting, And Accessory Instruments

GMDN Terms

Code Name
35868 Dental restoration retention pin

Identifiers

Type ID
Primary D661T1071
Unit of Use D661T1070