FDA.reportPublic FDA data

AutoLap Single procedure kit Pack (Clip, 5mm)

Primary DI
17290016648284
Brand
AutoLap Single procedure kit Pack (Clip, 5mm)
Company
M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Model
ASS06620US
Device description
The single procedure kit box contains: Clip unit 1/box, Clippers set (5mm)- 1 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
27290016648281PackageGS16In Commercial Distribution
17290016648284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001664828127290016648281
1729001664828417290016648284

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).

Regulatory Flags#

DUNS number
649827193
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
27290016648281AutoLap Single procedure kit Pack (Clip, 5mm)ASS06620US2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01