AccessGUDID - DEVICE: Symmetry Surgical (00887482155745)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical
Version or Model: SGH1032
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482155745
Issuing Agency: GS1
Commercial Distribution End Date: September 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Secto® Handle, Laparoscopic, (SGH10 at 20 cm WL), Short, 10 mm, 20.5 cm Working Length, Reusable

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?
63868	Laparoscopic surgery handle	A hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synthetic material with a straight handle grip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	Laparoscope, Gynecologic (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982428	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: f61e6b67-b97f-41a7-8fef-b1fcd251ab28
Public Version Date: May 15, 2025
Public Version Number: 2
DI Record Publish Date: September 09, 2024