GERTIE MARX SPINAL N

GUDID B27425101I0

SPINAL NEEDLE

International Medical Development Corporation

Spinal needle, single-use

• Primary Device ID: B27425101I0
• NIH Device Record Key: cd5e975c-cd49-4b0d-88b8-88ade7c2949e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GERTIE MARX SPINAL N
• Version Model Number: GM25101-I
• Company DUNS: 078483253
• Company Name: International Medical Development Corporation
• 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: true
• 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	B27425101I0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070354

FDA Product Code

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

Sterilization

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

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

[B27425101I0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-11
• Device Publish Date: 2023-09-01

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