FDA.reportPublic FDA data

Orthopaedic Suction Set

Primary DI
06970754496159
Brand
Orthopaedic Suction Set
Company
GCMEDICA ENTERPRISE LTD. (WUXI)
Model
AEEFS1111
Device description
Sterile, single use, easyflow filtered suction system, for orthopaedic surgery.
Published
2023-09-08
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

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970754496156PackageGS110In Commercial Distribution
06970754496159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697075449615616970754496156
06970754496159069707544961596970754496159

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Regulatory Flags#

DUNS number
527142751
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16970754496156Orthopaedic Suction SetAEEFS11112023-09-08
16970754494862Dynarex CorporationGC1957R082023-02-04
36970754494866Dynarex CorporationGC1957R082023-02-04
06970754494728GcmedicaGC0652DD2022-12-09
06970754494735GcmedicaGC0653DD2022-12-09
06970754494742GcmedicaGC0654DT2022-12-09
06970754496593NatusGC8022F011420020,Adult,52CM*2+32CM,Clear2022-12-09
06970754496609NatusGC8022F011420050,Adult,52CM*2+2.15M,Clear2022-12-09
06970754496616NatusGC8022F121420030,Pediatric,52CM*2+92CM,Clear2022-12-09
06970754496623NatusGC8022F031420040,Infant,52CM*2+92CM,Clear2022-12-09
06970754496777De Soutter MedicalGC1433C1U2022-12-09
06970754498467GcmedicaGC0654DD2022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196035458MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196995561MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041873ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041880ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253038941ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253038958ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253039672ArgyleCardinal Health 200, LLCJOL2024-12-04
10192253003628ArgyleCardinal Health 200, LLCJOL2024-10-09
10192253002928ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002935ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002942ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253057294ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057300ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057317ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057324ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057348ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057355ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057362ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057379ArgyleCardinal Health 200, LLCJOL2024-08-02