AccessGUDID - DEVICE: Brighton™ (00884450088692)

GUDID

Device Identifier (DI) Information

Brand Name: Brighton™
Version or Model: 00884450088692
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BP-10F-SP-350/A
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450088692
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

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):	No
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?
34916	Anaesthesia conduction catheter holder, sterile	A sterile device in the form of an adhesive backed pad with a locking mechanism that is used to secure an anaesthesia conduction catheter at the skin insertion site to prevent catheter migration. Also known as an epidural securement device. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, electrosurgical, endoscopic (with or without accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: Usable Length-137.8" (350 cm)
Device Size Text, specify: Generator Type-Single Plug Bipolar

Device Record Status

Public Device Record Key: 5a2c05c4-5194-42ae-ac4b-d4242bed5c5f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016