FDA.reportPublic FDA data

Orthopedic Suction Set

Primary DI
06974500613494
Brand
Orthopedic Suction Set
Company
GCMEDICA ENTERPRISE LTD.(WUXI)
Model
JF01G01
Device description
including:1 Handle,2 Filters, 4 tips with 2 eyes per end (11cm straight, 15cm curved, 23cm curved, 28cm straight )
Published
2025-12-04
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
16974500613491PackageGS120In Commercial Distribution
06974500613494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697450061349116974500613491
06974500613494069745006134946974500613494

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Regulatory Flags#

DUNS number
560122957
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
06974500612718Rigid Uterine Aspiration CuretteGC7049A07AU012026-05-18
06974500612725Rigid Uterine Aspiration CuretteGC7049A08AU012026-05-18
06974500612732Rigid Uterine Aspiration CuretteGC7049A09AU012026-05-18
06974500612749Rigid Uterine Aspiration CuretteGC7049A10AU012026-05-18
06974500612756Rigid Uterine Aspiration CuretteGC7049A11AU012026-05-18
06974500612763Rigid Uterine Aspiration CuretteGC7049A12AU012026-05-18
06974500612770Rigid Uterine Aspiration CuretteGC7049A14AU012026-05-18
06974500612787Rigid Uterine Aspiration CuretteGC7049A16AU012026-05-18
06974500612794Rigid Uterine Aspiration CuretteGC7049D14AU012026-05-18
06974500612824Rigid Uterine Aspiration CuretteGC7049B07BU012026-05-18
06974500612831Rigid Uterine Aspiration CuretteGC7049B08BU012026-05-18
06974500612848Rigid Uterine Aspiration CuretteGC7049B09BU012026-05-18
06974500612855Rigid Uterine Aspiration CuretteGC7049B10BU012026-05-18
06974500612862Rigid Uterine Aspiration CuretteGC7049B11BU012026-05-18
06974500612879Rigid Uterine Aspiration CuretteGC7049B12BU012026-05-18
06974500612886Rigid Uterine Aspiration CuretteGC7049B14BU012026-05-18
06974500612893Rigid Uterine Aspiration CuretteGC7049B16BU012026-05-18
06974500612909Rigid Uterine Aspiration CuretteGC7049E14BU012026-05-18
06974500613333Flexible Uterine Aspiration CuretteGC7049C04AU012026-05-18
06974500613340Flexible Uterine Aspiration CuretteGC7049C05AU012026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
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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
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