FDA UDI In Commercial Distribution 🇺🇸 United States

SURGICAL INSTRUMENT

DI: 07899995238146 · Model: EXFN 03 · Sin Sistema de Implante Nacional S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SURGICAL INSTRUMENT
Primary DI
07899995238146
Version / Model
EXFN 03
Catalog Number
EXFN 03
Company Name
Sin Sistema de Implante Nacional S/A
Labeler DUNS
904569092
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-05
Public Version
2
Public Version Date
2025-11-20
Public Version Status
Update
Public Device Record Key
df101539-62fa-445f-b934-e3ae06c556d3

Device Description

DRIVER EXTENSOR OF DRILL MOD.03

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Identifiers

Type ID
Primary 07899995238146