FDA.reportPublic FDA data

Trackable Suction - Tube 6-L-30

Primary DI
00670082000153
Brand
Trackable Suction - Tube 6-L-30
Company
Synaptive Medical Inc
Model
SYN-0651
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10670082000150PackageGS13In Commercial Distribution
00670082000153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067008200015010670082000150
00670082000153006700820001536700820001530670082000153

GMDN Terms#

Term, Definition table
TermDefinition
Suction cannula, reusableA rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203061833
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670082000214Trackable Suction - Tube 12-L-30SYN-06532017-02-28
00670082000221Trackable Suction - Tube 6-L-90SYN-06542017-02-28
00670082000238Trackable Suction - Tube 10-L-90SYN-06552017-02-28
00670082000245Trackable Suction - Tube 12-L-90SYN-06562017-02-28
00670082000276Trackable Suction - Tube 4-S-30SYN-06712017-06-30
00670082000283Trackable Suction - Tube 6-S-30SYN-06722017-06-30
00670082000290Trackable Suction - Tube 8-S-30SYN-06732017-06-30
00670082000306Trackable Suction - Tube 10-S-30SYN-06742017-06-30
00670082000313Trackable Suction - Tube 4-M-30SYN-06752017-06-30
00670082000320Trackable Suction - Tube 6-M-30SYN-06762017-06-30
00670082000337Trackable Suction - Tube 8-M-30SYN-06772017-06-30
00670082000344Trackable Suction - Tube 10-M-30SYN-06782017-06-30
00670082000450EvrySYN-07772020-06-05
00670082000252Multi-Tool Calibration DeviceSYN-07552023-01-03
00670082000269Short PointerSYN-05592023-01-03
00670082000351Sterilizable Storage TraySYN-07542023-01-03
00670082000467Modus VSYN-09022020-06-05
00670082000474Modus VSYN-09032020-06-05
00670082000504Modus Nav Software2.1SYN-08672022-12-23
00670082000528Modus Nav Operator CartSYN-09822022-12-23

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Primary DI, Brand, Company table
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