FDA.reportPublic FDA data

Gross Ear Hook

Primary DI
00192896105249
Brand
Gross Ear Hook
Company
SONTEC INSTRUMENTS, INC.
Model
467-448S
Device description
Gross Ear Hook and Curette
Published
2020-10-16
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
JYLHOOK, MICROSURGICAL EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896105249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896105249001928961052491928961052490192896105249

GMDN Terms#

Term, Definition table
TermDefinition
Ear spoonA hand-held manual surgical instrument intended to be used during interventions in the ear to remove or manipulate tissue or anatomical structures. It is usually made of high-grade stainless steel and has a cylindrical handle located centrally from which a shaft protrudes in both directions. These shafts terminate with an operative instrument, one of which is spoon-shaped. The opposite tip may be, e.g., blunt or pointed and possibly at a right angle to the shaft. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.875Inch

Sterilization Methods#

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

Contacts#

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

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00192896038110SONTEC-MICHELE TREPHINE419-392419-3922018-09-11
00192896038127SONTEC-MICHELE TREPHINE419-393419-3932018-09-11
00192896038134SONTEC-MICHELE TREPHINE419-394419-3942018-09-11
00192896038141SONTEC-MICHELE TREPHINE419-395419-3952018-09-11
00192896038158SONTEC-MICHELE TREPHINE419-396419-3962018-09-11
00192896038165SONTEC-MICHELE TREPHINE419-397419-3972018-09-11
00192896038172SONTEC-MICHELE TREPHINE419-398419-3982018-09-11
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00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07

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Primary DI, Brand, Company table
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09348811108364INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
09348811149886INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
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