FDA.reportPublic FDA data

SHEEHY-HOUSE POWDER INSUFFLATOR

Primary DI
00850000126053
Brand
SHEEHY-HOUSE POWDER INSUFFLATOR
Company
Oto-Med, Inc.
Model
S-3001
Device description
SHEEHY-HOUSE POWDER INSUFFLATOR
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00850000126053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000126053008500001260538500001260530850000126053

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

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
059817742
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000126077spineX BONE DUST COLLECTORS-45002018-09-21
00850000126169CI UNIVERSAL DRAPESD-23002021-11-19
00850000126084GLASSCOCK OTOLOGY SURGERY DRAPESD-21002018-09-21
00850000126091GLASSCOCK NEUROTOLOGY SURGERY DRAPESD-22002018-09-21
10850000126166CI UNIVERSAL DRAPESD-23002021-11-19
00850000126121OTOMED® SUCTION TUBINGSP-40002018-09-21
00850000126152LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
10850000126159LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
00850000126015GLASSCOCK® EAR DRESSING, ADULTS-10002018-09-21
00850000126022GLASSCOCK® EAR DRESSING, PEDIATRICS-10032018-09-21
00850000126046SHEEHY BONE DUST COLLECTORS-25002018-09-21
00850000126060COX BONE DUST COLLECTORS-35002018-09-21
00850000126138EAR DRESSING, ADULTS-10002020-11-30
00850000126145EAR DRESSING, PEDIATRICS-10032020-11-30
10850000126135EAR DRESSING, ADULTS-10002020-11-30
10850000126142EAR DRESSING, PEDIATRICS-10032020-11-30
00850000126039HEAD & NECK PRESSURE DRESSINGS-1010-22018-09-21
00850000126114LEVINE IRRIGATION-SUCTION KITSP-30002018-09-21
00850000126107SAFETRAP TISSUE COLLECTORSP-20002018-09-21

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