EACU, EAKU, ZAGU, JOCU

GUDID B338LJ4040R2

Maanshan Bond Medical Instruments Co., Ltd.

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

• Primary Device ID: B338LJ4040R2
• NIH Device Record Key: d3f41ea0-c7dc-4685-8174-4e6876bcedaf
• Commercial Distribution Discontinuation: 2030-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EACU, EAKU, ZAGU, JOCU
• Version Model Number: LJ4040R
• Company DUNS: 421257620
• Company Name: Maanshan Bond Medical Instruments 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: false
• 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
HIBCC	B338LJ4040R0 [Unit of Use]
HIBCC	B338LJ4040R1 [Primary]
HIBCC	B338LJ4040R2 [Package]; Contains: B338LJ4040R1; Package: bigger box [10 Units]; Discontinued: 2030-01-01; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150903

FDA Product Code

• MQX: Needle, Acupuncture, Single Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-24
• Device Publish Date: 2021-09-16

On-Brand Devices [EACU, EAKU, ZAGU, JOCU]

• B338SIX30502: SIX3050
• B338SIX25402: SIX2540
• B338SIX20302: SIX2030
• B338Q30602: Q3060
• B338Q30502: Q3050
• B338Q16302: Q1630
• B338L30752: L3075
• B338L30602: L3060
• B338L30502: L3050
• B338L30402: L3040
• B338L30302: L3030
• B338L25402: L2540
• B338L25302: L2530
• B338L20302: L2030
• B338L18302: L1830
• B338L16251: L1625
• B338G30502: G3050
• B338G16302: G1630
• B338C30502: C3050
• B338C16252: C1625
• B338PB22151: PB2215
• B338PB20151: PB2015
• B338PB18151: PB1815
• B338PB16151: PB1615
• B338P30751: P3075
• B338P30502: P3050
• B338P30401: P3040
• B338P25752: P2575
• B338P25502: P2550
• B338P25402: P2540
• B338P25301: P2530
• B338P22502: P2250
• B338P22402: P2240
• B338P22301: P2230
• B338P22152: P2215
• B338P20401: P2040
• B338P20302: P2030
• B338P20152: P2015
• B338P18402: P1840
• B338P18302: P1830
• B338P18152: P1815
• B338P16402: P1640
• B338P16302: P1630
• B338P16152: P1615
• B338P14302: P1430
• B338P14152: P1415
• B338P12402: P1240
• B338P12302: P1230
• B338P12151: P1215
• B338NKJ30502: NKJ3050