AccessGUDID - DEVICE: Symmetry Surgical (00887482173671)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical
Version or Model: 50-9610
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482173671
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Speculum, Fansler Operating, 1 3/8 in Diameter

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?
33395	Ear speculum, reusable	A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDF	Speculum, Vaginal, Metal

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: 646d4c48-4e4d-4bf4-9878-ba98b9d7d7db
Public Version Date: April 30, 2025
Public Version Number: 2
DI Record Publish Date: September 09, 2024