AccessGUDID - DEVICE: miniRUMEL™ (00850200006582)

GUDID

Device Identifier (DI) Information

Brand Name: miniRUMEL™
Version or Model: 080130
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 080130
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850200006582
Issuing Agency: GS1
Commercial Distribution End Date: October 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 603420183 *Terms of Use

Device Description: miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device.

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Minimum suture length required to use miniRUMEL™ Device.
Length: 30 Inch

Device Record Status

Public Device Record Key: b6f875de-bbf8-4069-8df5-4cfc8d7c1f08
Public Version Date: October 29, 2021
Public Version Number: 5
DI Record Publish Date: July 03, 2020