FDA UDI In Commercial Distribution 🇺🇸 United States

AutoLap Sterile Components Kit Package- Ring, 5mm

DI: 27290016648304 · Model: ASS02140US · M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AutoLap Sterile Components Kit Package- Ring, 5mm
Primary DI
27290016648304
Version / Model
ASS02140US
Company Name
M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Labeler DUNS
649827193
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
809ba54f-1a26-4507-86db-e5acb1ec2c76

Device Description

The kit contains: 1X Ring units box (6 Ring units/box), 3X 5mm Clippers set box (2 sets/box)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, General & Plastic Surgery

GMDN Terms

Code Name
16240 Laparoscope holder

Identifiers

Type ID
Primary 27290016648304

Premarket Submissions

Submission Number Supplement Number
K131375 000
K152848 000