AccessGUDID - DEVICE: AutoLap Single Procedure Kit Pack- (Ring, 5mm) (17290016648260)

GUDID

Device Identifier (DI) Information

Brand Name: AutoLap Single Procedure Kit Pack- (Ring, 5mm)
Version or Model: ASS06520US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD

Primary DI Number: 17290016648260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649827193 *Terms of Use

Device Description: The Ring procedure kit box contains: Ring unit- 1/box, Clippers set (5mm)- 1/box

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16240	Laparoscope holder	A 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).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131375	000
K152848	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80a74a6d-1be6-4e77-ae12-750349d27249
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016