ALARA® 11 Gauge Access Needle - Diamond Tip

GUDID 00850040139488

SURGENTEC, LLC

Surgical drill guide, single-use

• Primary Device ID: 00850040139488
• NIH Device Record Key: 4f635ea7-fe94-41dd-89ca-0ae39c39f673
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALARA® 11 Gauge Access Needle - Diamond Tip
• Version Model Number: AAN-09
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• Device Count: 1
• DM Exempt: false
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850040139488 [Primary]

FDA Product Code

• GDF: Guide, Needle, Surgical

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: 2025-05-07
• Device Publish Date: 2025-04-29

Devices Manufactured by SURGENTEC, LLC

• 00810131881375 - ALARA 11 Gauge Access Needle with Sheath - Bevel Tip: 2025-05-07
• 00810131881382 - ALARA 11 Gauge Access Needle with Sheath - Diamond Tip: 2025-05-07
• 00850040139471 - ALARA® 11 Gauge Access Needle - Bevel Tip: 2025-05-07
• 00850040139488 - ALARA® 11 Gauge Access Needle - Diamond Tip: 2025-05-07
• 00850040139488 - ALARA® 11 Gauge Access Needle - Diamond Tip: 2025-05-07
• 00850040139495 - ALARA® 11 Gauge Access Needle Two Pack- Bevel Tip: 2025-05-07
• 00850040139501 - ALARA® 11 Gauge Access Needle Two Pack- Diamond & Bevel Tip: 2025-05-07
• 00850040139518 - ALARA® 11 Gauge Access Needle Two Pack- Diamond Tip: 2025-05-07
• 00850040139525 - ALARA® 11 Gauge Access Needle with Sheath - Bevel Tip: 2025-05-07