AccessGUDID - DEVICE: MiroCam Capsule Endoscope System (08809260260375)

GUDID

Device Identifier (DI) Information

Brand Name: MiroCam Capsule Endoscope System
Version or Model: MC1000-B, MR1100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IntroMedic Co., LTD.

Primary DI Number: 08809260260375
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631065794 *Terms of Use

Device Description: Package System(MC1000-B Capsule and MR1100 Receiver)

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):	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?
44836	Video capsule endoscopy system	An assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. The system typically consists of an operator workstation, various types of video capsules, an external sensor device that receives the wireless signals from the capsule, and a data recorder. As the capsule passes through the GI tract, video images of it sections (e.g., oesophagus, small bowel and colon) are relayed to the operator for examination and data recording; the capsule is egested from the gut.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140751	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 4e6ba327-cd6c-44c1-8cb5-c50eb9314528
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 31, 2017