AccessGUDID - DEVICE: N/A (10885403057106)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 4324A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4324A
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403057106
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: Myelogram Tray, 22 G x 3 1/2 Inch Spinal Needle For Use with Water Soluble Contrast Media

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?
35199	Myelography kit	A collection of devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. It is also referred to as myelogram tray and typically includes a needle, syringe, tubing, contrast medium, and other consumable items. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PWY	Lumbar puncture tray (adult & pediatric)

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: 50ed2169-2043-419d-99e8-5c3e510ebbdf
Public Version Date: December 25, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2016