FDA.reportPublic FDA data

Centurion

Primary DI
10653160110774
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
IGSS0570
Catalog number
IGSS0570
Device description
IRRIGATION SPLASH SHIELD
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYZSYRINGE, IRRIGATING (NON DENTAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653160110774PackageGS150In Commercial Distribution
00653160110777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316011077410653160110774
00653160110777006531601107776531601107770653160110777

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653160294248CenturionMNS101552016-11-11
00653160315974CenturionCIT66352018-04-09
00653160284218CenturionCIT59202017-03-03
00653160274882CenturionPE31802018-02-11
00653160389753CenturionDM485BDM485B2025-09-17
00653160389296CenturionBT235BBT235B2025-08-24
00653160389319CenturionCSS640ACSS640A2025-08-24
00653160389494CenturionDT23104DT231042025-08-24
00653160388992CenturionSUT14785ASUT14785A2025-08-18
00653160389357CenturionDT23103DT231032025-08-18
00653160389067CenturionDYNDV2722DYNDV27222025-08-09
00653160389074CenturionSUT19525ASUT19525A2025-08-09
00653160389159CenturionIVS1090BIVS1090B2025-08-09
00653160388978CenturionMNS10875BMNS10875B2025-08-02
00653160386936CenturionIVS4222IVS42222025-07-21
00653160388909CenturionSUT21465BSUT21465B2025-07-21
00653160388848CenturionDYNDC3166DDYNDC3166D2025-07-18
00653160388732CenturionSUT19955BSUT19955B2025-07-14
00653160388770CenturionDM875ADM875A2025-07-14
00653160388794CenturionSUT12485ASUT12485A2025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00861092002606CeaLogic Ratio Applicator KitRECIBIO, INC.KYZ2026-03-01
00850027492995NavägeRhinosystems, Inc.KYZ2026-02-23
50192253068854MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068860MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068885MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068892MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253007449MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007487MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007518MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007531MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007555MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007730MonojectCardinal Health 200, LLCKYZ2025-12-15
00850063139441Neil Medical Group Neil Medical GroupKYZ2025-12-08
05413765580970RECOTHROM SPRAY KITBAXTER HEALTHCARE CORPORATIONKYZ2025-12-01
50198956194647CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
50198956181548CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
00810180841931Syringes without Needle, Non-Toxic, Luer Slip, 20 ML Dynarex CorporationKYZ2025-05-30
00810180841948Syringes without Needle, Non-Toxic, Luer Slip, 60 MLDynarex CorporationKYZ2025-05-30
10661392002255LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002262LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002842LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
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10661392002927LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004440LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004457LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004464LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008394LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008400LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008417LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008424LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16