AccessGUDID - DEVICE: LAPAROVUE (20845854061739)

GUDID

Device Identifier (DI) Information

Brand Name: LAPAROVUE
Version or Model: LAPVUE03
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LAPVUE03
Company Name: Conmed Corporation

Primary DI Number: 20845854061739
Issuing Agency: GS1
Commercial Distribution End Date: December 08, 2020
Device Count: 3
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: LaparoVue Visibility System Laparoscopic Solutions

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?
38835	Surgical instrument/endoscope cleaning utensil, single-use	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 40 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 40 Degrees Celsius
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47cad023-f992-4b8b-aa8e-a280a1633424
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: June 01, 2020