AccessGUDID - DEVICE: CODMAN FLEX1 (10886704034995)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN FLEX1
Version or Model: 70028
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70028
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704034995
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: Replacement Connector with Strain Relief Sleeve

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:	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?
47079	Spinal infusion/drainage catheter	A sterile flexible tube intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column for infusion of materials (typically anaesthetic or analgesic substances during surgery, labour, or delivery), and/or drainage of cerebrospinal fluid (CSF) and/or other fluids. Devices intended to assist catheter insertion (e.g., Tuohy needle, suture) may be included. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LKK	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890055	018
P890055	021
P890055	026
P890055	027

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
No Device Sizes

Device Record Status

Public Device Record Key: ffeb7683-a6ee-4518-bad7-692235de8b97
Public Version Date: September 15, 2023
Public Version Number: 4
DI Record Publish Date: September 20, 2014