AccessGUDID - DEVICE: Sidecar External Working Channel (00854924006118)

GUDID

Device Identifier (DI) Information

Brand Name: Sidecar External Working Channel
Version or Model: FG-1011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-1011
Company Name: C2 THERAPEUTICS, INC.

Primary DI Number: 00854924006118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929139249 *Terms of Use

Device Description: Sidecar External Working Channel, Endoscopic Accessory

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":	Yes
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?
37090	Endoscope assembly adaptor	A connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	Endoscopic Access Overtube, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150083	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: b82a114e-de08-41ac-846f-09dc479cc45e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 19, 2016