FDA UDI In Commercial Distribution 🇺🇸 United States

EVONOS

DI: 00821925018457 · Model: 130435 · Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
EVONOS
Primary DI
00821925018457
Version / Model
130435
Company Name
Gyrus ACMI, LLC
Labeler DUNS
007198742
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-10
Public Version
4
Public Version Date
2024-09-02
Public Version Status
Update
Public Device Record Key
fdd398f3-a514-4f96-ac49-34ac47accd1c

Device Description

FARRIOR RASP .50 MM TIP DIAMETER STAINLESS STEEL EBONY FINISH

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

Sterilization

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

Product Codes

Code Name
LRC INSTRUMENT, ENT MANUAL SURGICAL

GMDN Terms

Code Name
35295 Middle ear file/rasp

Identifiers

Type ID
Primary 00821925018457