FDA.reportPublic FDA data

AutoLap Curved ARM

Primary DI
07290016648034
Brand
AutoLap Curved ARM
Company
M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Model
MST-03-0101
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
17290016648031PackageGS11Not in Commercial Distribution
07290016648034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001664803117290016648031
07290016648034072900166480347290016648034

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, power-adjustedA device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649827193
Device count
1
Serial number
true
Manufacturing 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
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
27290016648281AutoLap Single procedure kit Pack (Clip, 5mm)ASS06620US2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18