Access Needle (8 Gauge) F005.0002

GUDID B922F005000201

Access Needle (8 Gauge)

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Bone access cannula

• Primary Device ID: B922F005000201
• NIH Device Record Key: b09562cd-3135-4e07-b1f4-033378c26f06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Needle (8 Gauge)
• Version Model Number: F005.0002
• Catalog Number: F005.0002
• Company DUNS: 860396609
• Company Name: INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(214)972-8683
• Email: info@indiusmedical.com
• Phone: +1(214)972-8683
• Email: info@indiusmedical.com
• Phone: +1(214)972-8683
• Email: info@indiusmedical.com
• Phone: +1(214)972-8683
• Email: info@indiusmedical.com
• Phone: +1(214)972-8683
• Email: info@indiusmedical.com
• Phone: +1(214)972-8683
• Email: info@indiusmedical.com
• Phone: +1(214)972-8683
• Email: info@indiusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B922F005000201 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B922F005000201]

Moist Heat or Steam Sterilization

[B922F005000201]

Moist Heat or Steam Sterilization

[B922F005000201]

Moist Heat or Steam Sterilization

[B922F005000201]

Moist Heat or Steam Sterilization

[B922F005000201]

Moist Heat or Steam Sterilization

[B922F005000201]

Moist Heat or Steam Sterilization

[B922F005000201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-17
• Device Publish Date: 2026-03-09

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