AccessGUDID - DEVICE: MICROLAP (10653405006145)

GUDID

Device Identifier (DI) Information

Brand Name: MICROLAP
Version or Model: C-LIL-SEAL-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-LIL-SEAL-1
Company Name: Conmed Corporation

Primary DI Number: 10653405006145
Issuing Agency: GS1
Commercial Distribution End Date: July 27, 2021
Device Count: 25
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: MICROLAP TROCAR SEAL, SINGLE USE (1/STERILE)

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?
45597	Laparoscopic access cannula seal reducer, single-use	A small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140101	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
Special Storage Condition, Specify: KEEP DRY
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f785a5c6-592c-47eb-8b25-11558975e4a8
Public Version Date: July 25, 2024
Public Version Number: 5
DI Record Publish Date: April 18, 2017