FDA UDI Not in Commercial Distribution 🇺🇸 United States

AutoLap ARM

DI: 07290016648027 · Model: MST-02-0101 · M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AutoLap ARM
Primary DI
07290016648027
Version / Model
MST-02-0101
Company Name
M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Labeler DUNS
649827193
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
4
Public Version Date
2019-03-11
Public Version Status
Update
Public Device Record Key
d31b0208-83dc-4cad-a023-4098f9b59a92
Distribution End Date
2017-01-19

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, General & Plastic Surgery

GMDN Terms

Code Name
62380 Surgical instrument assist arm system, power-adjusted

Identifiers

Type ID
Primary 07290016648027
Package 17290016648024

Premarket Submissions

Submission Number Supplement Number
K131375 000
K152848 000