FDA.reportPublic FDA data

Centurion

Primary DI
00653160024166
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
4022
Catalog number
4022
Device description
EAR AND ULCER SYRINGE
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGQEar irrigation kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGQEar Irrigation KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50653160024161PackageGS150In Commercial Distribution
00653160024166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5065316002416150653160024161
00653160024166006531600241666531600241660653160024166

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation kit, single-useA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manual syringe and other accessory items. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02
10653160292562CENTURIONMNS9820MNS98202022-01-02
10653160293798CENTURIONIV8310EIV8310E2017-08-18
10653160310006CENTURIONID2060ID20602021-11-29
10653160313243CENTURIONSUT20670SUT206702022-01-02
10653160313823CENTURIONSUT20685SUT206852022-01-02
10653160316626CENTURIONMNS11230MNS112302018-05-03
10653160317210CENTURIONTC7955TC79552022-01-02
10653160318170CENTURIONOR2050OR20502022-01-02
10653160318361CENTURIONMNS11280MNS112802022-01-01
10653160319160CENTURIONIV8675IV86752018-07-16
10653160323211CENTURIONMNS11745MNS117452022-01-01
10653160324065CENTURIONMNS11760MNS117602022-01-01
10653160325000CENTURIONCIT6905CIT69052022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16971919462535Medi GradeNingbo Albert Novosino Co.,Ltd.OGQ2025-12-29
16971919460500Medi GradeNingbo Albert Novosino Co.,Ltd.OGQ2025-11-20
00714646000675Ear Wax Removal KitBionix, LLCOGQ2024-07-11
00691835141008caring millBlue Echo Care LLCOGQ2024-06-20
00810025926854caring millBlue Echo Care LLCOGQ2024-06-20
00860007911446Cleanse RightBlue Echo Care LLCOGQ2024-06-20
00860007911453Cleanse RightBlue Echo Care LLCOGQ2024-06-20
00860007911460Cleanse RightBlue Echo Care LLCOGQ2024-06-20
10714646000672Ear Wax Removal Kit 12 Ct. CaseBionix, LLCOGQ2022-10-27
00653160205695CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2022-01-01
10653160205692CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2022-01-01
00653160022766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
00653160023602CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
50653160022761CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
50653160023607CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
50653160024161CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
00031046605065Ezy Dose Self-CareAPOTHECARY PRODUCTS, LLCOGQ2021-03-26
20031046605069Ezy Dose Self-CareAPOTHECARY PRODUCTS, LLCOGQ2021-03-26
M572HBS033C114011Conformis Hip SystemConformis, Inc.OGQ2019-12-12
00783349000015Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31
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00783349000114Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31
00783349000299Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31
00783349000374Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31