Superion Handle 100-9139

GUDID 00884662000352

Superion Handle

VERTIFLEX, INC.

Lumbar interspinous decompression instrument set, reusable

• Primary Device ID: 00884662000352
• NIH Device Record Key: 53cb47d2-485d-418a-b942-3e59f4e7f2c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Superion Handle
• Version Model Number: N/A
• Catalog Number: 100-9139
• Company DUNS: 005235436
• Company Name: VERTIFLEX, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884662000352 [Primary]

FDA Product Code

• NQO: Prosthesis, Spinous Process Spacer/Plate

Sterilization

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

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

[00884662000352]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-16

Devices Manufactured by VERTIFLEX, INC.

• 00884662000529 - Superion Indirect Decompression System: 2020-10-06 Superion Indirect Decompression System, 8mm
• 00884662000574 - Superion IDS Kit: 2019-07-25 Superion IDS Kit includes a Driver (102-9108), Inserter (102-9110), & Interspinous Gauge (102-9115)
• 00884662000611 - Vertiflex Instrument Platform: 2019-07-25 Vertiflex Instrument Platform includes a Dilator Assembly (140-9501), Cannula Assembly (140-9502), & Reamer (140-9503)
• 00088466000529 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 8mm
• 00884662000536 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 10mm
• 00884662000543 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 12mm
• 00884662000550 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 14mm
• 00884662000567 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 16mm