AccessGUDID - DEVICE: IEC-Innoview GmbH (B192300083000)

GUDID

Device Identifier (DI) Information

Brand Name: IEC-Innoview GmbH
Version or Model: 30-0083-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-0083-00
Company Name: INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

Primary DI Number: B192300083000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010741028 *Terms of Use

Device Description: 10.0 mm, 30 deg. Thoracoscope, l=170mm, autoclavable

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):	No
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?
35398	Rigid optical thoracoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the thoracic cavity. It is inserted through an incision made in the chest into the intercostal cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable 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 [?]
K982276	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 30 degree
Outer Diameter: 10.0 Millimeter
Length: 170 Millimeter

Device Record Status

Public Device Record Key: 8104011e-2b25-4188-9938-d6df1e5a4917
Public Version Date: November 08, 2019
Public Version Number: 5
DI Record Publish Date: June 02, 2016