UNIMAX 122-18B

GUDID 00852647007580

SQUARE BOLT EXTENDED B TYPE

PARAMOUNT SURGICALS, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00852647007580
• NIH Device Record Key: 44fff194-7671-44c9-b6b6-1d043a24ef88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIMAX
• Version Model Number: 122-18B
• Catalog Number: 122-18B
• Company DUNS: 015483156
• Company Name: PARAMOUNT SURGICALS, 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: true
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com
• Phone: 956-541-1220
• Email: param@paramountsurgicals.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852647007580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014302

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

[00852647007580]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-01

On-Brand Devices [UNIMAX]

• 00852647007979: SMALL FLANGE NUT APPLICATOR
• 00852647007962: LARGE FLANGE NUT APPLICATOR
• 00852647007955: BONE SCREW APPLICATOR
• 00852647007597: CAP WASHER 3 MM
• 00852647007580: SQUARE BOLT EXTENDED B TYPE
• 00852647007573: SQUARE BOLT EXTENDED
• 00852647007566: SQUARE BOLT MEDIUM
• 00852647007559: SQUARE BOLT REGULAR
• 00852647007542: FLANGE NUT LARGE
• 00852647007535: FLANGE NUT SMALL
• 00852647007528: ZERO DEGREE WASHER
• 00852647007511: VERTICAL PLATE OFFSET 93 MM
• 00852647007504: VERTICAL PLATE OFFSET 79 MM
• 00852647007498: VERTICAL PLATE OFFSET 65 MM
• 00852647007481: VERTICAL PLATE OFFSET 52 MM
• 00852647007474: VERTICAL PLATE OFFSET 38 MM
• 00852647007467: VERTICAL PLATE OFFSET 120 MM
• 00852647007450: VERTICAL PLATE OFFSET 106 MM
• 00852647007443: VERTICAL PLATE STANDARD 86 MM
• 00852647007436: VERTICAL PLATE STANDARD 72 MM
• 00852647007429: VERTICAL PLATE STANDARD 59 MM
• 00852647007412: VERTICAL PLATE STANDARD 45 MM
• 00852647007405: VERTICAL PLATE STANDARD 31 MM
• 00852647007399: VERTICAL PLATE STANDARD 113 MM
• 00852647007382: VERTICAL PLATE STANDARD 100 MM
• 00852647007375: HORIZONTAL PLATE OFFSET B TYPE 72.5 MM
• 00852647007368: HORIZONTAL PLATE STANDARD 72.5 MM
• 00852647007351: HORIZONTAL PLATE OFFSET B TYPE 70 MM
• 00852647007344: HORIZONTAL PLATE STANDARD 70 MM
• 00852647007337: HORIZONTAL PLATE OFFSET B TYPE 67.5 MM
• 00852647007320: HORIZONTAL PLATE STANDARD 67.5 MM
• 00852647007313: HORIZONTAL PLATE OFFSET B TYPE 65 MM
• 00852647007306: HORIZONTAL PLATE STANDARD 65 MM
• 00852647007290: HORIZONTAL PLATE OFFSET B TYPE 62.5 MM
• 00852647007283: HORIZONTAL PLATE STANDARD 62.5 MM
• 00852647007276: HORIZONTAL PLATE OFFSET B TYPE 60 MM
• 00852647007269: HORIZONTAL PLATE STANDARD 60 MM
• 00852647007252: HORIZONTAL PLATE OFFSET B TYPE 57.5 MM
• 00852647007245: HORIZONTAL PLATE STANDARD 57.5 MM
• 00852647007238: HORIZONTAL PLATE OFFSET B TYPE 55 MM
• 00852647007221: HORIZONTAL PLATE STANDARD 55 MM
• 00852647007214: HORIZONTAL PLATE OFFSET B TYPE 52.5 MM
• 00852647007207: HORIZONTAL PLATE STANDARD 52.5 MM
• 00852647007191: HORIZONTAL PLATE OFFSET B TYPE 50 MM
• 00852647007184: HORIZONTAL PLATE STANDARD 50 MM
• 00852647007177: HORIZONTAL PLATE OFFSET B TYPE 47.5 MM
• 00852647007160: HORIZONTAL PLATE STANDARD 47.5 MM
• 00852647007153: HORIZONTAL PLATE OFFSET B TYPE 45 MM
• 00852647007146: HORIZONTAL PLATE STANDARD 45 MM
• 00852647007139: HORIZONTAL PLATE OFFSET B TYPE 42.5 MM