AccessGUDID - DEVICE: MICROLAP (30653405037501)

GUDID

Device Identifier (DI) Information

Brand Name: MICROLAP
Version or Model: MK-1500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MK-1500
Company Name: Conmed Corporation

Primary DI Number: 30653405037501
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2017
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Primary Second Site Introducer with Insufflation Needle

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:	No
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?
12750	Spring-loaded pneumoperitoneum needle, single-use	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943810	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Secondary Introducer
Device Size Text, specify: Primary Introducer

Device Record Status

Public Device Record Key: 0c1aed0c-cd1e-46c8-8888-c5e3414f95c9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016