AccessGUDID - DEVICE: BD Whitacre Spinal NRFit (00382904009731)

GUDID

Device Identifier (DI) Information

Brand Name: BD Whitacre Spinal NRFit
Version or Model: 400973
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400973
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904009731
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: BD® Whitacre Spinal NRFit™ Needle, 25G x 4 11/16 in.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
35212	Spinal needle, single-use	A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193131	000

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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 626eb447-b03b-47ab-8ffe-0c181abf428b
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: March 21, 2022