FDA.reportPublic FDA data

KABIERSKE POWDER BLOWER SET

Primary DI
00192896039322
Brand
KABIERSKE POWDER BLOWER SET
Company
SONTEC INSTRUMENTS, INC.
Model
465-400
Catalog number
465-400
Device description
KABIERSKE POWDER BLOWER SET
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
KCLBLOWER, POWDER, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCLBlower, Powder, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896039322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896039322001928960393221928960393220192896039322

GMDN Terms#

Term, Definition table
TermDefinition
ENT powder applicatorAn applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896040885Antrum Grasping Forceps468-360468-3602018-09-10
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09
00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
00192896097063Laparoscopic Bulldog Clamp2901-281-402901-281-402019-05-09
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183527938BR Surgical, LLCBR Surgical, LLCKCL2024-10-18
00840183512088BR Surgical, LLCBR Surgical, LLCKCL2024-06-03
00840183520021BR Surgical, LLCBR Surgical, LLCKCL2024-06-03
05060259073021DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCL2023-10-05
25060259073025DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCL2023-10-05
04048551057278n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057285n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057322n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057339n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057353n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057315n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057469n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057476n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
00850000126053SHEEHY-HOUSE POWDER INSUFFLATOROto-Med, Inc.KCL2018-09-21
00192896039339KABIERSKE POWDER BLOWER CANNULASONTEC INSTRUMENTS, INC.KCL2018-09-12
04048551057292n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057308n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057360n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057377n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057384n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057391n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057346n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057445n.a.Karl Storz GmbH & Co. KGKCL2018-09-04