AccessGUDID - DEVICE: NA (05060247262123)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Niagara MED1455
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MED1455
Company Name: MEDISAFE UK LIMITED

Primary DI Number: 05060247262123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 505942961 *Terms of Use

Device Description: The Niagara MED1455 Instrument Carrier accommodates up to 20 EndoWrist instruments. Additional Levels on the carrier are provided for the loading of accessories used with the da Vinci systems.

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):	No
Over the Counter (OTC):	Yes
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?
62151	Sterilizer/disinfector rack	A non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEC	Disinfector, medical devices

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07c1a61b-0f1b-42a4-b7d6-d8d0980ea7a4
Public Version Date: March 09, 2021
Public Version Number: 5
DI Record Publish Date: September 20, 2016