Syringe w/Needle

GUDID 00616784700632

DYNAREX CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 00616784700632
• NIH Device Record Key: ac27c483-2a58-4652-807f-fe8a50ce0a78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syringe w/Needle
• Version Model Number: 7006
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 100
• DM Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784700618 [Unit of Use]
GS1	00616784700625 [Primary]
GS1	00616784700632 [Package]; Contains: 00616784700625; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112057

FDA Product Code

• FMF: Syringe, Piston

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: 2016-09-24

On-Brand Devices [Syringe w/Needle]

• 00616784701639: 7016
• 00616784701530: 7015
• 00616784701431: 7014
• 00616784701332: 7013
• 00616784701233: 7012
• 00616784701134: 7011
• 00616784701035: 7010
• 00616784700939: 7009
• 00616784700830: 7008
• 00616784700731: 7007
• 00616784700632: 7006
• 00616784700533: 7005
• 00616784700434: 7004
• 00616784700335: 7003
• 00616784700236: 7002
• 00616784700137: 7001
• 00616784700038: 7000
• 00616784699936: 6999
• 00616784699837: 6998
• 00616784699738: 6997
• 00616784699639: 6996
• 00616784699530: 6995
• 00616784699431: 6994