FDA UDI In Commercial Distribution 🇺🇸 United States

Lexicon

DI: D716GP06AS1 · Model: GP06AS · TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Lexicon
Primary DI
D716GP06AS1
Version / Model
GP06AS
Catalog Number
GP06AS
Company Name
TULSA DENTAL PRODUCTS LLC
Labeler DUNS
942778564
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-30
Public Version
1
Public Version Date
2022-09-07
Public Version Status
New
Public Device Record Key
f2495cc1-7cb8-4f1b-9279-70d710584e71

Device Description

Gutta-Percha 120pk 06 15-40

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Liquid Chemical

Product Codes

Code Name
EKM GUTTA-PERCHA

GMDN Terms

Code Name
45081 Synthetic gutta-percha

Identifiers

Type ID
Primary D716GP06AS1