BD Whitacre Spinal

Basic Information

• Brand Name: BD Whitacre Spinal
• Primary DI: 00382904003715
• Version / Model: 400371
• Catalog Number: 400371
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 001292192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-02
• Public Version: 2
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: fc223003-0f0a-440c-83b6-0fd6f6ccc836

Device Description

NDL SP S/SU 27GA 4-11/16IN WHITACRE CE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50382904003710	GS1	Case	5	In Commercial Distribution
Package	30382904003716	GS1	Shelfpack	10	In Commercial Distribution
Primary	00382904003715	GS1

Premarket Submissions

Submission Number	Supplement Number
K210978	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature