Energy Flo Value-Pak J Type Acupuncture Needles

GUDID B517100457010

Acu Market

Acupuncture needle, single-use

• Primary Device ID: B517100457010
• NIH Device Record Key: 1d923bc3-09cc-4695-b430-0a032a79457f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Energy Flo Value-Pak J Type Acupuncture Needles
• Version Model Number: CE-03V 0.18X30MM J-TYPE VALUE PAK
• Company DUNS: 150890841
• Company Name: Acu Market
• Device Count: 20000
• 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

Device Dimensions

• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 0.18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B517100457010 [Primary]
HIBCC	B5171004570101 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002411

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-21

On-Brand Devices [Energy Flo Value-Pak J Type Acupuncture Needles]

• B517100457010: CE-03V 0.18X30MM J-TYPE VALUE PAK
• B5171004570: CE-03V 0.18X30MM J-TYPE VALUE PAK
• B517100456010: CE-03V 0.25X30MM J-TYPE VALUE PAK
• B5171004560: CE-03V 0.25X30MM J-TYPE VALUE PAK
• B517100455010: CE-03V 0.20X30MM J-TYPE VALUE PAK
• B5171004550: CE-03V 0.20X30MM J-TYPE VALUE PAK
• B517100453010: CE-03V 0.16X30MM J-TYPE VALUE PAK
• B5171004530: CE-03V 0.16X30MM J-TYPE VALUE PAK
• B517100452010: CE-03V 0.16X15MM J-TYPE VALUE PAK
• B5171004520: CE-03V 0.16X15MM J-TYPE VALUE PAK
• B51710051201: CE-03V 0.25X50MM J-TYPE VALUE PAK
• B51710051001: CE-03V 0.14X30MM J-TYPE VALUE PAK
• B51710050901: CE-03V 0.25X40MM J-TYPE VALUE PAK
• B51710050801: CE-03V 0.30X75MM J-TYPE VALUE PAK
• B51710045901: CE-03V 0.14X15MM J-TYPE VALUE PAK