FDA.reportPublic FDA data

KABIERSKE POWDER BLOWER CANNULA

Primary DI
00192896039339
Brand
KABIERSKE POWDER BLOWER CANNULA
Company
SONTEC INSTRUMENTS, INC.
Model
465-400F
Catalog number
465-400F
Device description
KABIERSKE POWDER BLOWER CANNULA
Published
2018-09-12
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
00192896039339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896039339001928960393391928960393390192896039339

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Centimeter

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
+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
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
00192896123427Trocar20910-1120910-112026-06-02
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
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
00192896094567ROCHESTER CARMALT FORCEPS1100-150Q1100-150Q2019-03-07
00192896094758BLAKESLEY ETHMOID RONGEUR468-686468-6862019-03-07
00192896095861ETHMOID PEDIATRIC RONGEUR468-590Q468-590Q2019-03-25
00192896041028ETHMOID PEDIATRIC RONGEUR468-580468-5802018-09-10
00192896041035ETHMOID PEDIATRIC RONGEUR468-585468-5852018-09-11
00192896041042ETHMOID PEDIATRIC RONGEUR468-590468-5902018-09-10
00192896041059WILDE ETHMOID RONGEUR468-600468-6002018-09-10
00192896041066WILDE ETHMOID RONGEUR468-606468-6062018-09-11

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
00192896039322KABIERSKE POWDER BLOWER SETSONTEC INSTRUMENTS, INC.KCL2018-09-17
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