FDA.reportPublic FDA data

GSO

Primary DI
06975803530969
Brand
GSO
Company
Group Supply Organization Medical Technology(Shanghai) Ltd
Model
GSY60-CT
Device description
Piston Irrigation Syringe 60ml, with Catheter tip, non-sterile
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
16975803530966PackageGS130In Commercial Distribution
26975803530963PackageGS16In Commercial Distribution
06975803530969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697580353096616975803530966
2697580353096326975803530963
06975803530969069758035309696975803530969

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.

Regulatory Flags#

DUNS number
554525912
Device count
1
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
16975803530805GSOGCB15LF2025-11-30
16975803530812GSOGCB25LF2025-11-30
16975803530829GSOGCB35LF2025-11-30
16975803530836GSOGCB45LF2025-11-30
16975803530843GSOGCB25LFS2025-11-30
16975803530850GSOGCB45LFS2025-11-30
16975803530867GSOGCB25LFC2025-11-30
16975803530881GSOGC01B2025-11-30
26975803530802GSOGCB15LF2025-11-30
26975803530819GSOGCB25LF2025-11-30
26975803530826GSOGCB35LF2025-11-30
26975803530833GSOGCB45LF2025-11-30
26975803530840GSOGCB25LFS2025-11-30
26975803530857GSOGCB45LFS2025-11-30
26975803530864GSOGCB25LFC2025-11-30
16975803530874GSOGCB25LFB2025-11-30
26975803530888GSOGC01B2025-11-30
06975803530594GSOGDTC1840SS2023-03-06
06975803530600GSOGDTC2440SS2023-03-06
06975803530617GSOGDTC3040SS2023-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956501645CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-06-08
10198956466579CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-05-19
10653160392859Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KYZ2026-04-08
10192253068856MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253068863MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068884MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068891MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253007442MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007480MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007510MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007534MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007558MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007732MonojectCardinal Health 200, LLCKYZ2025-12-15
00661392004474LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392007437LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010734LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010758LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055124LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055155LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
10198956204768CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-10
10198956194649CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
10198956181540CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
10704411006152AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007074AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007098AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
00661392002258LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002265LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002845LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002852LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002920LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16