Pencil Point Spinal Needle

GUDID 06955741822609

22G x 4 3/4" (120mm) ,sterile, with Introducer(19G*40mm)

Shanghai SA Medical & Plastic Instruments Co., Ltd.

Spinal needle, single-use

• Primary Device ID: 06955741822609
• NIH Device Record Key: f22f94c5-bd0f-40c7-a9cc-edf0aafa2f9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pencil Point Spinal Needle
• Version Model Number: AN-S II
• Company DUNS: 654447549
• Company Name: Shanghai SA Medical & Plastic Instruments Co., Ltd.
• Device Count: 1
• 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: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com
• Phone: 513-271-2117
• Email: jbarrett@havels.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06955741822609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120475

FDA Product Code

• BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)

Sterilization

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

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

[06955741822609]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-05
• Device Publish Date: 2020-04-27

On-Brand Devices [Pencil Point Spinal Needle]

• 06955741822623: 22G x 6" (150mm),sterile, with Introducer(19G*40mm)
• 06955741822609: 22G x 4 3/4" (120mm) ,sterile, with Introducer(19G*40mm)
• 06955741822586: 22G x 4" (103mm),sterile, with Introducer(19G*40mm)
• 06955741822562: 22G x 3 1/2" (90mm) ,sterile, with Introducer (19G*30mm)
• 06955741822401: 24G x 6" (150mm) ,sterile, with Introducer(20G*40mm)
• 06955741822388: 24G x 4 3/4" (120mm) ,sterile, with Introducer(20G*40mm)
• 06955741822364: 24G x 4" (103mm),sterile, with Introducer(20G*40mm)
• 06955741822340: 24G x 3 1/2" (90mm), sterile, with Introducer(20G*30mm)
• 06955741822289: 25G x 4 3/4" (120mm),sterile, with Introducer(20G*40mm)
• 06955741822241: 25G x 3 1/2" (90mm) ,sterile, with Introducer(20G*30mm)
• 06955741823316: 22G*90mm, sterile