AccessGUDID - DEVICE: Symmetry SECTO® (00887482154212)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry SECTO®
Version or Model: 81-1011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482154212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Secto® Sponge, Tonsil, Medium, Single use/sterile, 1 in Diameter; Cord Length 10 in; (5 ea/pouch; 25 pouches/pk; 2 pk/bx)

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:	Yes
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?
13698	Dissection sponge	A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	Gauze/Sponge, Internal, X-Ray Detectable

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Inch
Device Size Text, specify: 1 in Diameter

Device Record Status

Public Device Record Key: 87aeae2e-c079-4189-ba72-0c1192e78b60
Public Version Date: May 13, 2025
Public Version Number: 2
DI Record Publish Date: September 04, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
10887482154219	5	00887482154212	In Commercial Distribution
20887482154216	24	10887482154219	In Commercial Distribution
00887482154229	50	20887482154216	In Commercial Distribution