FDA.reportPublic FDA data

AutoLap Sterile Components Kit Package- Ring, 10mm

Primary DI
27290016648298
Brand
AutoLap Sterile Components Kit Package- Ring, 10mm
Company
M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Model
ASS02130US
Device description
The kit contains: 1 X Ring units box (6 Ring units/box), 3 X 10mm Clippers set box (2 Clippers set/box)
Published
2016-09-20
Public version status
Update
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131375000
K152848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131375000AUTOLAP SYSTEMMst - Medical Surgery Technologies , Ltd.2013-09-19GCJ
K152848000AUTOLAP SYSTEMM.S.T Medical Surgery Technologies, Ltd.2015-11-17GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290016648298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001664829827290016648298

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscope holderA device intended to be used to hold, maintain in a desired position, and allow positional adjustment of, a laparoscope and associated instruments/devices during laparoscopy; it may also be intended to hold/position other surgical devices (e.g., retractors, manipulators) during other endoscopic or open surgical procedures. It typically consists of joints, rigid or semi-rigid arms, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649827193
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016648102AutoLap Bar ExtenderMST-02-01112017-02-13
17290016648079AutoLap ARM Unit PackageASS060302017-01-19
17290016648246AutoLap Sterile DrapeASS07018US2016-09-20
07290016648027AutoLap ARMMST-02-01012016-09-20
07290016648034AutoLap Curved ARMMST-03-01012016-09-20
07290016648058AutoLap CartMST-10-01002016-09-20
07290016648072AutoLap ARM UnitMST-15-01002017-01-19
07290016648089AutoLap BarMST-03-01022017-01-19
07290016648096AutoLap Curved BarMST-03-01042017-01-19
17290016648109AutoLap Bar ExtenderMST-02-01112017-02-13
07290016648119Autolap CartMST-12-01002017-06-28
07290016648331AutoLap Sterile DrapeASS07022US2017-02-13
17290016648277AutoLap Single Procedure Kit Pack (Clip, 10mm)ASS06610US2016-09-20
17290016648284AutoLap Single procedure kit Pack (Clip, 5mm)ASS06620US2016-09-20
17290016648062AutoLap Touch ScreenASS060102016-09-20
17290016648208Ring Command Unit PackageASS050022016-09-20
17290016648222Molded Laparoscopic Clipper Package- 5mmASS06015US2016-09-20
17290016648239Molded Laparoscopic Clippers package- 10mmASS06014US2016-09-20
17290016648260AutoLap Single Procedure Kit Pack- (Ring, 5mm)ASS06520US2016-09-20
27290016648274AutoLap Single Procedure Kit Pack (Clip, 10mm)ASS06610US2016-09-20

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Primary DI, Brand, Company table
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