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#

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00192896123670Meyerding Finger Retractor205-857Q205-857Q2026-08-27
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00192896122048Ceramitec Universal Klick Ferris Smith Rongeur Shaft404-312B404-312B2026-08-25
00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24
00192896123533Rochester Carmalt Forceps1100-152LQ1100-152LQ2026-06-24
00192896123540Green Retractor207-298207-2982026-06-24
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
00192896038110SONTEC-MICHELE TREPHINE419-392419-3922018-09-11
00192896038127SONTEC-MICHELE TREPHINE419-393419-3932018-09-11

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