FDA UDI In Commercial Distribution 🇺🇸 United States

GUBISH SURGICAL PEN HOLDER SET

DI: 00192896075696 · Model: 117-593 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GUBISH SURGICAL PEN HOLDER SET
Primary DI
00192896075696
Version / Model
117-593
Catalog Number
117-593
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-19
Public Version
1
Public Version Date
2018-10-22
Public Version Status
New
Public Device Record Key
f4d06409-0ac1-4237-9e62-1547c3b4c3d9

Device Description

GUBISH SURGICAL PEN HOLDER SET

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
["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
EMF KNIFE, SURGICAL

GMDN Terms

Code Name
12255 Tonsil knife

Identifiers

Type ID
Primary 00192896075696

Customer Contacts

Device Sizes

Type Value Unit Text
Length 13 Centimeter