AccessGUDID - DEVICE: CONTIPLEX® (04046964991561)

GUDID

Device Identifier (DI) Information

Brand Name: CONTIPLEX®
Version or Model: 331642
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 331642
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964991561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Contiplex® Tuohy Ultra 360 Set, 18 Ga. X 6 in. Insulated Echogenic Needle (CNB600TU3)

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:	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?
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	Active	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Gauge (cannula) : 18
Device Size Text, specify: Gauge (Catheter) : 20

Device Record Status

Public Device Record Key: 0016ed77-e050-4664-a792-6c465603c082
Public Version Date: November 12, 2020
Public Version Number: 6
DI Record Publish Date: March 02, 2017