ShurFit ACIF 2C 62-BK-0601

GUDID 00840019932691

ACIF 2C Wide Kit Case BOM

PRECISION SPINE, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00840019932691
• NIH Device Record Key: 5b22ce2f-5b40-47b1-8b5f-d62b75894e28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit ACIF 2C
• Version Model Number: 62-BK-0601
• Catalog Number: 62-BK-0601
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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	00840019932691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161809

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

[00840019932691]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-27
• Device Publish Date: 2019-08-19

On-Brand Devices [ShurFit ACIF 2C]

• 00840019921480: ACIF 2C Instrument Case - Expanded
• 00840019921473: ACIF 2C Instrument Case - Expanded + Double Wide
• 00840019921466: ACIF 2C Instrument Case - Standard
• 00840019921459: Carry Case, Sterile Product ACIF 2C
• 00840019921442: ACIF Trial, 18 x 15 x 12
• 00840019921428: ACIF Trial, 18 x 15 x 10
• 00840019921411: ACIF Trial, 18 x 15 x 9
• 00840019921398: ACIF Trial, 18 x 15 x 7
• 00840019921381: ACIF Trial, 18 x 15 x 6
• 00840019921374: ACIF Trial, 18 x 15 x 5
• 00840019921367: ACIF Trial, 16 x 14 x 12
• 00840019921350: ACIF Trial, 16 x 14 x 11
• 00840019921343: ACIF Trial, 16 x 14 x 10
• 00840019921336: ACIF Trial, 16 x 14 x 9
• 00840019921329: ACIF Trial, 16 x 14 x 8
• 00840019921312: ACIF Trial, 16 x 14 x 7
• 00840019921305: ACIF Trial, 16 x 14 x 6
• 00840019921299: ACIF Trial, 16 x 14 x 5
• 00840019921282: ACIF Trial, 14 x 12 x 12
• 00840019921275: ACIF Trial, 14 x 12 x 11
• 00840019921268: ACIF Trial, 14 x 12 x 10
• 00840019921251: ACIF Trial, 14 x 12 x 9
• 00840019921220: ACIF Trial, 14 x 12 x 6
• 00840019921206: ACIF Rasp, 18 x 15 x 12 w/ Stop
• 00840019921176: ACIF Rasp, 18 x 15 x 9 w/ Stop
• 00840019921169: ACIF Rasp, 18 x 15 x 8 w/ Stop
• 00840019921138: ACIF Rasp, 18 x 15 x 5 w/ Stop
• 00840019921114: ACIF Rasp, 18 x 15 x 11
• 00840019921107: ACIF Rasp, 18 x 15 x 10
• 00840019921091: ACIF Rasp, 18 x 15 x 9
• 00840019921077: ACIF Rasp, 18 x 15 x 7
• 00840019921046: Endplate Rasp
• 00840019921435: ACIF Trial, 18 x 15 x 11
• 00840019921404: ACIF Trial, 18 x 15 x 8
• 00840019921244: ACIF Trial, 14 x 12 x 8
• 00840019921237: ACIF Trial, 14 x 12 x 7
• 00840019921213: ACIF Trial, 14 x 12 x 5
• 00840019921190: ACIF Rasp, 18 x 15 x 11 w/ Stop
• 00840019921183: ACIF Rasp, 18 x 15 x 10 w/ Stop
• 00840019921152: ACIF Rasp, 18 x 15 x 7 w/ Stop
• 00840019921145: ACIF Rasp, 18 x 15 x 6 w/ Stop
• 00840019921121: ACIF Rasp, 18 x 15 x 12
• 00840019921084: ACIF Rasp, 18 x 15 x 8
• 00840019921060: ACIF Rasp, 18 x 15 x 6
• 00840019921053: ACIF Rasp, 18 x 15 x 5
• 00815362020647: CpTi + HA Coated ACIF Cage Peek 05 degree x 5mm
• 00815362020951: CpTi + HA Coated ACIF Wide Cage Peek 10 degree x 12mm
• 00815362020944: CpTi + HA Coated ACIF Wide Cage Peek 10 degree x 11mm
• 00815362020937: CpTi + HA Coated ACIF Wide Cage Peek 10 degree x 10mm
• 00815362020920: CpTi + HA Coated ACIF Wide Cage Peek 10 degree x 9mm