AccessGUDID - DEVICE: MICROLAP (10653405005803)

GUDID

Device Identifier (DI) Information

Brand Name: MICROLAP
Version or Model: C-COEP35100H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-COEP35100H
Company Name: Conmed Corporation

Primary DI Number: 10653405005803
Issuing Agency: GS1
Commercial Distribution End Date: June 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: MICROLAP OBTURATOR, HELICAL, 3.5 MM X 100 MM

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:	No
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?
33596	Endoscopic electrosurgical handpiece/electrode, monopolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify: KEEP DRY
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3.5 MM X 100 MM

Device Record Status

Public Device Record Key: c5740145-9af3-42d3-850c-6e559dfe077c
Public Version Date: June 28, 2022
Public Version Number: 4
DI Record Publish Date: April 18, 2017