FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660110260
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Kuhn frontal sinus seeker
Catalog number
44-956
Device description
Kuhn frontal sinus seeker, double-ended, size #3, hexagonal handle
Published
2021-01-04
Public version status
New
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
00190660110260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660110260001906601102601906601102600190660110260

GMDN Terms#

Term, Definition table
TermDefinition
Fistula probeA slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, designed for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811115829INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-04-24
09348811005106INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-03-18
00714646001535Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
10714646001532Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
00714646001627Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
09348811115836INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-25
09348811112149INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
09348811150448INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
04250676728609Tube probeSpiggle & Theis Medizintechnik GmbHKAK2025-10-10
04250676731982Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676731999Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732002Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732026Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732033Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740625Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740632Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740649Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740656Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740663Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740687Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740694Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740700Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740717Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
00190776409487MillenniumAvalign Technologies, Inc.KAK2025-09-02
00757770407972Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00757770636334Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00194613044404MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613048952MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613059804MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613102227MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01