FDA.reportPublic FDA data

ENDOLARYNGEAL PROBE

Primary DI
00192896058705
Brand
ENDOLARYNGEAL PROBE
Company
SONTEC INSTRUMENTS, INC.
Model
1301-515
Catalog number
1301-515
Device description
ENDOLARYNGEAL PROBE MICROSCOPIC STRAIGHT BUTTON-END
Published
2018-09-27
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
KAKPROBE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896058705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896058705001928960587051928960587050192896058705

GMDN Terms#

Term, Definition table
TermDefinition
Microlaryngeal probeA hand-held manual surgical instrument designed for paediatric laryngology and for phonatory microsurgery applications in adults. This delicate probe gives a precise sense of palpation for accurate detection of induration, tissue mass, and cystic changes. It is also used to break thick mucus fluid before its extraction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9.5Inch
Length10Inch

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
Sterilization required before use
true

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00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09348811115836INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-25
09348811112149INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
09348811150448INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
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04250676740632Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
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04250676740687Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
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04250676740717Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
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