AccessGUDID - DEVICE: Symmetry OPTI-LENGTH® GARRETT (00887482027394)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry OPTI-LENGTH® GARRETT
Version or Model: 67-7395
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 67-7395
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482027394
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Vascular Dilator, Malleable Shaft, 3.5 Mm, 9 1/2"

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Vascular dilator, reusable	A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Vascular dilator, reusable

A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
DWP	Dilator, Vessel, Surgical

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 325e7d69-45cf-467e-be24-e68e3f9964d4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 01, 2016