FDA UDI In Commercial Distribution 🇺🇸 United States

LEONE SPA

DI: 08033707097433 · Model: F1102-22 · LEONE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
LEONE SPA
Primary DI
08033707097433
Version / Model
F1102-22
Catalog Number
F1102-22
Company Name
LEONE SPA
Labeler DUNS
432167294
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-18
Public Version
1
Public Version Date
2020-11-26
Public Version Status
New
Public Device Record Key
5e1b2b9b-65a7-4422-b1f7-2eacbb68368b

Device Description

BKT 22 INTERACTIVE SL 22 T+10 A+8

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
No

Product Codes

Code Name
EJF Bracket, Metal, Orthodontic

GMDN Terms

Code Name
58818 Self-ligating orthodontic bracket

Identifiers

Type ID
Primary 08033707097433