FDA.report

Symmetry Surgical®

Primary DI
00887482123874
Company
SYMMETRY SURGICAL INC.
Model
72-6046
Catalog number
72-6046
Device description
Symmetry® Suction Tube, Jackson Velvet Eye Aspirating Tube, 4 mm Diameter, 12 Fr, 10 in, 254 mm
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00887482123874PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00887482123874PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KARIrrigator, Sinus1Ear, Nose, Throat874.4420NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn 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 reusable device.

Device Sizes

TypeValueText
Catheter Gauge12 French
Device Size Text, specify04 mm Diameter
Length10 Inch

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

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