FDA.reportPublic FDA data

Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector

Primary DI
10856312006066
Brand
Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector
Company
KATALYST SURGICAL LLC
Model
DN1405-160
Device description
Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector
Published
2016-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FSTLight, Surgical, Fiberoptic
HBIIlluminator, Fiberoptic, Surgical Field

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2
HBIIlluminator, Fiberoptic, Surgical FieldGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141781000KOGENT SPETZLER LIGHTED SUCTION TUBESKatalyst Surgical, LLC2015-04-09HBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856312006066PrimaryGS10
00856312006069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085631200606610856312006066
00856312006069008563120060698563120060690856312006069

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, illuminating, single-useAn atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. 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. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as 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 tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007883297
Device count
5
Lot or batch
true
Expiration date on label
true

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