FDA.reportPublic FDA data

IODINE CUP

Primary DI
00192896070745
Brand
IODINE CUP
Company
SONTEC INSTRUMENTS, INC.
Model
ST14-G
Catalog number
ST14-G
Device description
IODINE CUP
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896070745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896070745001928960707451928960707450192896070745

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic osteosynthesis system sonotrode tipAn electrode-like device attached to a dedicated ultrasonic osteosynthesis system handpiece used to apply high frequency mechanical oscillation (ultrasonic vibration) to a resorbable fixation pin on a surgically-drilled bone tunnel. The ultrasonic vibration is used to create friction and then heat so that the pin will flow into the tunnel and solidify (weld) with underlying porous bone after energy removal. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
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00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
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00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

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