AccessGUDID - DEVICE: Savary-Gilliard (00827002214156)

GUDID

Device Identifier (DI) Information

Brand Name: Savary-Gilliard
Version or Model: G21415
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SGD-100-2
Company Name: COOK INCORPORATED

Primary DI Number: 00827002214156
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 079720472 *Terms of Use

Device Description: Savary-Gilliard Dilator Set

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):	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?
35009	Over-guidewire oesophageal dilator	A surgical instrument in the form of a slender, hollow cylinder made of metal, plastic or other suitable material, designed to dilate oesophageal strictures/passages after being passed over a pre-positioned guidewire, typically in sequentially increasing sizes. It is commonly used prior to and to assist in a gastroscopy and is available in a variety of sizes and flexibilities. Commonly known as a Savary-Guillard dilator it will typically be used during fluoroscopy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, esophageal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Store in dark, dry, cool place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d77546b0-5859-4db4-af73-6a16fc7de476
Public Version Date: October 15, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016