AccessGUDID - DEVICE: Design Options® (04046964322129)

GUDID

Device Identifier (DI) Information

Brand Name: Design Options®
Version or Model: 570170
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 570170
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964322129
Issuing Agency: GS1
Commercial Distribution End Date: March 28, 2017
Device Count: 10
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: PNB/Support Tray

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
47191	Anaesthesia conduction catheterization kit	A collection of sterile devices and materials intended for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management. The kit consists of an anaesthesia catheter with devices dedicated to catheter introduction/function (e.g., tunneller, needle, sheath) and includes non-dedicated supportive devices (e.g., dressings, adhesive strips). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OGJ	Nerve block tray

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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ca7af95-403b-4a9c-a7b5-64e9d3b8df52
Public Version Date: June 12, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016