FDA UDI In Commercial Distribution 🇺🇸 United States

Endodontic Absorbent Paper Points

DI: D716AP04601 · Model: AP0460 · TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
120

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Basic Information

Brand Name
Endodontic Absorbent Paper Points
Primary DI
D716AP04601
Version / Model
AP0460
Catalog Number
AP0460
Company Name
TULSA DENTAL PRODUCTS LLC
Labeler DUNS
942778564
Distribution Status
In Commercial Distribution
Device Count in Pkg
120
Record Status
Published
Publish Date
2022-10-26
Public Version
1
Public Version Date
2022-11-03
Public Version Status
New
Public Device Record Key
3a5b13c3-5367-4e22-b621-3de823ba4e40

Device Description

Lexicon Absorbent Paper Point 04/60

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
EKN POINT, PAPER, ENDODONTIC

GMDN Terms

Code Name
38777 Endodontic paper point

Identifiers

Type ID
Unit of Use D716AP04600
Primary D716AP04601