FDA UDI In Commercial Distribution 🇺🇸 United States

McILWRAITH BISTOURI KNIFE

DI: 00192896057197 · Model: 1271-155 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
McILWRAITH BISTOURI KNIFE
Primary DI
00192896057197
Version / Model
1271-155
Catalog Number
1271-155
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-27
Public Version
2
Public Version Date
2020-08-20
Public Version Status
Update
Public Device Record Key
3cf9fa52-79c0-42a9-a4f0-ebbc9fbde3ce

Device Description

McILWRAITH BISTOURI KNIFE BUTTON END CURVED BLADE

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code Name
HTS KNIFE, ORTHOPEDIC

GMDN Terms

Code Name
37837 Orthopaedic osteotome blade, reusable

Identifiers

Type ID
Primary 00192896057197

Customer Contacts

Device Sizes

Type Value Unit Text
Device Size Text, specify 55 Millimeter Blade
Length 7 Inch