AccessGUDID - DEVICE: InnerVue II 100mm Scope Kit (00851582006085)

GUDID

Device Identifier (DI) Information

Brand Name: InnerVue II 100mm Scope Kit
Version or Model: 922142
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BVTKIT72-1R2A0
Company Name: BIOVISION TECHNOLOGIES, LLC

Primary DI Number: 00851582006085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 166160106 *Terms of Use

Device Description: 1.2mm Disposable InnerVue II Scope with Accessories 100mm WL, 10 Degree

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?
35616	Endoscopic video imaging system	An assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082293	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
Length: 100 Millimeter
Angle: 10 degree
Outer Diameter: 1.2 Millimeter

Device Record Status

Public Device Record Key: a48037dd-09bb-4010-b512-85042ea6506a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 17, 2016