AccessGUDID - DEVICE: miniARM® multiSTATION™ System (00850012846093)

GUDID

Device Identifier (DI) Information

Brand Name: miniARM® multiSTATION™ System
Version or Model: 081010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 081010
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850012846093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603420183 *Terms of Use

Device Description: M45™ CLICK RELEASE™ miniARM® Holder

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?
64146	Surgical instrument assist arm system structural component	A connecting component of a surgical instrument assist arm system intended to be integrated as part of the structural assembly of the arm. It is a structural component (not a repair tool) and may be in the form of an arm piece/rod, base unit, clamp, actuator, or instrument holding component; it is not intended to be used as the distal tissue interfacing instrument. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cb1af628-b1f2-4935-87e4-b945fd7128e5
Public Version Date: November 10, 2022
Public Version Number: 3
DI Record Publish Date: January 22, 2021