AccessGUDID - DEVICE: Symmetry Surgical® (00887482085585)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical®
Version or Model: 55-7165
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 55-7165
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482085585
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Symmetry® Dilator, Sarns, 5.2 mm Tip

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?
11266	Fixed-diameter cervical dilator, reusable	A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWP	Dilator, Vessel, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100518	000

Device Exempt from Premarket Submission: No 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: 504664cb-4017-4211-9fd2-6d426f5834ab
Public Version Date: January 21, 2025
Public Version Number: 2
DI Record Publish Date: September 25, 2018