AccessGUDID - DEVICE: Symmetry Farrell (00887482037898)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Farrell
Version or Model: 09-2116
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 09-2116
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482037898
Issuing Agency: GS1
Commercial Distribution End Date: September 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Applicator, Farrell Cotton, Serrated, 6 1/2 in

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?
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCJ	Applicator, Ent

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
Length: 6.5 Inch

Device Record Status

Public Device Record Key: 78c7c4fd-065c-468f-8031-441fd1979d60
Public Version Date: May 26, 2025
Public Version Number: 5
DI Record Publish Date: August 15, 2024