SIMPLEX/SARAL 322-2048

GUDID 00852647007863

2 LEVEL CERVICAL PLATE 48 MM

PARAMOUNT SURGICALS, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00852647007863
• NIH Device Record Key: de9a40ac-9764-4354-948a-e5560b32e706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLEX/SARAL
• Version Model Number: 322-2048
• Catalog Number: 322-2048
• 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

Device Dimensions

• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852647007863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070335

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

Moist Heat or Steam Sterilization

[00852647007863]

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 [SIMPLEX/SARAL]

• 00852647007993: CERVICAL DRILL BIT. 2.5 MM DIAMETER
• 00852647007986: CERVICAL SCREW REMOVER
• 00852647007948: 4 LEVEL CERVICAL PLATE 83 MM
• 00852647007931: 4 LEVEL CERVICAL PLATE 79 MM
• 00852647007924: 4 LEVEL CERVICAL PLATE 75 MM
• 00852647007917: 3 LEVEL CERVICAL PLATE 67 MM
• 00852647007900: 3 LEVEL CERVICAL PLATE 64 MM
• 00852647007894: 3 LEVEL CERVICAL PLATE 61 MM
• 00852647007887: 3 LEVEL CERVICAL PLATE 58 MM
• 00852647007870: 3 LEVEL CERVICAL PLATE 55 MM
• 00852647007863: 2 LEVEL CERVICAL PLATE 48 MM
• 00852647007856: 2 LEVEL CERVICAL PLATE 46 MM
• 00852647007849: 2 LEVEL CERVICAL PLATE 44 MM
• 00852647007832: 2 LEVEL CERVICAL PLATE 42 MM
• 00852647007825: 2 LEVEL CERVICAL PLATE 40 MM
• 00852647007818: 2 LEVEL CERVICAL PLATE 38 MM
• 00852647007801: 2 LEVEL CERVICAL PLATE 36 MM
• 00852647007795: 1 LEVEL CERVICAL PLATE 30 MM
• 00852647007788: 1 LEVEL CERVICAL PLATE 28 MM
• 00852647007771: 1 LEVEL CERVICAL PLATE 26 MM
• 00852647007764: 1 LEVEL CERVICAL PLATE 24 MM
• 00852647007757: 1 LEVEL CERVICAL PLATE 22 MM
• 00852647007740: 1 LEVEL CERVICAL PLATE 20 MM
• 00852647007733: 1 LEVEL CERVICAL PLATE 18 MM
• 00852647007726: RESCUE CERVICAL SCREW 17 MM
• 00852647007719: RESCUE CERVICAL SCREW 15 MM
• 00852647007702: RESCUE CERVICAL SCREW 13 MM
• 00852647007696: RESCUE CERVICAL SCREW 11 MM
• 00852647007689: SELF DRILLING CERVICAL SCREW 18 MM
• 00852647007672: SELF DRILLING CERVICAL SCREW 17 MM
• 00852647007665: SELF DRILLING CERVICAL SCREW 16 MM
• 00852647007658: SELF DRILLING CERVICAL SCREW 15 MM
• 00852647007641: SELF DRILING CERVICAL SCREW 14 MM
• 00852647007634: SELF DRILLING CERVVICAL SCREW 13 MM
• 00852647007627: SELF DRILLING CERVICAL SCREW, 12 MM
• 00852647007610: SELF DRILLING CERVICAL SCREW 11 MM
• 00852647007603: SELF DRILLING CERVICAL SCREW 10 MM