BD Integra 305311

GUDID 50382903053112

NEEDLE INTEGRA 25X1 RB TW

BECTON, DICKINSON AND COMPANY

Hypodermic needle, single-use

• Primary Device ID: 50382903053112
• NIH Device Record Key: 214b216a-566a-4533-8bbe-9901ec568aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Integra
• Version Model Number: 305311
• Catalog Number: 305311
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903053117 [Unit of Use]
GS1	30382903053118 [Primary]
GS1	50382903053112 [Package]; Contains: 30382903053118; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011103

FDA Product Code

• MEG: SYRINGE, ANTISTICK

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-16

On-Brand Devices [BD Integra]

• 50382903053136: NEEDLE INTEGRA 22X1-1/2 RB TW
• 50382903053129: NEEDLE INTEGRA 23X1 RB TW
• 50382903053112: NEEDLE INTEGRA 25X1 RB TW
• 50382903053105: NEEDLE INTEGRA 25X5/8 RB TW
• 50382903052832: SYRINGE INTEGRA 3ML LL
• 50382903052757: NEEDLE INTEGRA 18X1-1/2 BLUNT FILL
• 50382903052740: SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW
• 50382903052733: SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW
• 50382903052726: SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB
• 50382903052719: SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• 50382903052702: SYRINGE INTEGRA 3ML W/NDL 25X1 RB
• 50382903052696: SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB