FDA UDI In Commercial Distribution 🇺🇸 United States

MIS Inner Ear Suction Curette

DI: 00192896121829 · Model: 412-940 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MIS Inner Ear Suction Curette
Primary DI
00192896121829
Version / Model
412-940
Catalog Number
412-940
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-07-17
Public Version
1
Public Version Date
2025-07-25
Public Version Status
New
Public Device Record Key
d6e53e83-2811-4655-8fa7-374c6dae7403

Device Description

MIS Inner Ear Suction Curette Curved Oval 1.5 x 2.5 Millimeter With Suction Hole

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
Yes
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
Yes
Sterilization Methods
Dry Heat Sterilization

Product Codes

Code Name
LRC INSTRUMENT, ENT MANUAL SURGICAL

GMDN Terms

Code Name
47522 Endaural surgical curette, reusable

Identifiers

Type ID
Primary 00192896121829

Customer Contacts

Device Sizes

Type Value Unit Text
Length 130 Millimeter