FDA UDI In Commercial Distribution 🇺🇸 United States

EdgeEndo Biocermaic Sealer Tip

DI: 00810118106620 · Model: NEOPROT · NUSMILE, LTD.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
EdgeEndo Biocermaic Sealer Tip
Primary DI
00810118106620
Version / Model
NEOPROT
Company Name
NUSMILE, LTD.
Labeler DUNS
185497372
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-14
Public Version
1
Public Version Date
2026-01-22
Public Version Status
New
Public Device Record Key
0f220710-436c-4251-b6fc-924597965431

Device Description

EdgeEndo Biocermaic Sealer Tip 15 Pack

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
Yes
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
No
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

GMDN Terms

Code Name
60366 Dental material injection cannula, single-use

Identifiers

Type ID
Primary 00810118106620