DBC Sooji Hand Needle SooJi.Hand

GUDID 38800018900438

SooJi DBC Hand Needles are sterile disposable, stainless steel hand needles with "spring" style metal handle. Box contains 10 needles arranged for eas

Dong Bang Medical co.,Ltd.

Acupuncture needle, single-use Acupuncture needle, single-use

• Primary Device ID: 38800018900438
• NIH Device Record Key: b7a5f72b-7fd3-4d04-8b36-7f0067095193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBC Sooji Hand Needle
• Version Model Number: SooJi.Hand
• Catalog Number: SooJi.Hand
• Company DUNS: 689846367
• Company Name: Dong Bang Medical co.,Ltd.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-722-8775
• Email: customerservice@lhasaoms.com
• Phone: 800-722-8775
• Email: customerservice@lhasaoms.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800018900437 [Unit of Use]
GS1	18800018900434 [Primary]
GS1	28800018900431 [Package]; Contains: 18800018900434; Package: Case [10 Units]; In Commercial Distribution
GS1	38800018900438 [Package]; Contains: 28800018900431; Package: Master Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990328

FDA Product Code

• MQX: Needle, Acupuncture, Single Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-09

Devices Manufactured by Dong Bang Medical co.,Ltd.

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• 38800018900049 - DBC Spring Single: 2018-07-06 DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring"
• 38800018900056 - DBC Spring Single: 2018-07-06 DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring"
• 38800018900063 - DBC Spring Single: 2018-07-06 DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring"
• 38800018900070 - DBC Spring Single: 2018-07-06 DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring"
• 38800018900087 - DBC Spring Single: 2018-07-06 DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring"
• 38800018900094 - DBC Spring Single: 2018-07-06 DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring"