FDA UDI In Commercial Distribution 🇺🇸 United States

Barded Broach Maillefer

DI: D7166895522 · Model: 689552 · TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
Barded Broach Maillefer
Primary DI
D7166895522
Version / Model
689552
Catalog Number
689552
Company Name
TULSA DENTAL PRODUCTS LLC
Labeler DUNS
942778564
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2022-10-20
Public Version
1
Public Version Date
2022-10-28
Public Version Status
New
Public Device Record Key
ee5b2d09-bc68-4267-8773-d1d22ceb4100

Device Description

Barbed Broaches

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
EKW BROACH, ENDODONTIC

GMDN Terms

Code Name
63202 Endodontic broach, serrated, single-use

Identifiers

Type ID
Unit of Use D7166895521
Primary D7166895522