FDA UDI In Commercial Distribution 🇺🇸 United States

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DI: 00192896019430 · Model: 1103-7171 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
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Primary DI
00192896019430
Version / Model
1103-7171
Catalog Number
1103-7171
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-10
Public Version
8
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
005e478b-cd15-4d3b-aab7-7fc650fdc2b4

Device Description

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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
FSM Tray, Surgical, Instrument

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00192896019430

Customer Contacts

Device Sizes

Type Value Unit Text
Length 11 Inch
Height 1.5 Inch
Width 7 Inch