AccessGUDID - DEVICE: ROTH URETHRAL SUTURE GUIDE (00192896080492)

GUDID

Device Identifier (DI) Information

Brand Name: ROTH URETHRAL SUTURE GUIDE
Version or Model: 515-511
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 515-511
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896080492
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: ROTH URETHRAL SUTURE GUIDE

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?
32357	Suturing needle, reusable	A non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDM	NEEDLE, ASPIRATION AND INJECTION, REUSABLE

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 [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 28 French Inner Diameter

Device Record Status

Public Device Record Key: 3bf851ec-949f-49a3-ac3f-f4cc50c7baf7
Public Version Date: March 21, 2019
Public Version Number: 2
DI Record Publish Date: September 20, 2018