AccessGUDID - DEVICE: miniRUMEL™ (00850200006971)

GUDID

Device Identifier (DI) Information

Brand Name: miniRUMEL™
Version or Model: 080990
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 080990
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850200006971
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603420183 *Terms of Use
Previous DI: 00850200006582

Device Description: miniRUMEL™ DEVICE, 15cm

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?
63420	Suture/ligature tightener, single-use	A hand-held manual surgical instrument intended for the in situ tightening of a suture/ligature loop or a suture between a set of suture anchors (not included) during open and/or minimally-invasive surgery (e.g., vascular or gastrointestinal surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop for controlled manual tightening; some types may include a non-penetrating fastening device to secure suture ends. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR

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: 15 Centimeter
Device Size Text, specify: Minimum suture length for use with the device: 55 centimeters

Device Record Status

Public Device Record Key: dfc4ceb5-8c83-4459-b184-ef1df74b3a05
Public Version Date: November 10, 2022
Public Version Number: 3
DI Record Publish Date: October 09, 2020