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
00190776408695MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776408725MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776422813MillenniumAvalign Technologies, Inc.JOL2026-08-03
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424050Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114251000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143009NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114301120Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143012NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311080Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911437070Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143709NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911451123NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511310Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91145114510Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521020Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
00190776403959MillenniumAvalign Technologies, Inc.JOL2026-07-22
00190776403966MillenniumAvalign Technologies, Inc.JOL2026-07-22
00810220800492Adler Instrument CompanyAdler, Inc.JOL2026-07-17
00846159040678SCANLAN® Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040708SCANLAN®SCANLAN INTERNATIONAL INCJOL2026-07-17