ArmourSorb

GUDID 20749915002436

ArmourSorb Ray-Cot 1 1/2" x 1 1/2" (38 mm x 38 mm)

AMERICAN SURGICAL COMPANY, LLC

Neurosurgical sponge

• Primary Device ID: 20749915002436
• NIH Device Record Key: d3e3ac84-87e4-45f5-a0b7-60ec1897362f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArmourSorb
• Version Model Number: 88-14
• Company DUNS: 151054954
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Device Count: 15
• 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: 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
GS1	10749915002439 [Unit of Use]
GS1	20749915002436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112598

FDA Product Code

• HBA: Neurosurgical Paddie

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-16

On-Brand Devices [ArmourSorb]

• 30749915002365: ArmourSorb Ray-Cot 1/2" x 1/2" (13 mm x 13 mm)
• 20749915002450: ArmourSorb Ray-Cot 1/2" x 2" (13 mm x 51 mm)
• 20749915002443: ArmourSorb Ray-Cot 1/4" x 1 1/2" (6 mm x 38 mm)
• 20749915002436: ArmourSorb Ray-Cot 1 1/2" x 1 1/2" (38 mm x 38 mm)
• 20749915002429: ArmourSorb Ray-Cot 1" x 3" (25 mm x 76 mm)
• 20749915002412: ArmourSorb Ray-Cot 1" x 1" (25 mm x 25 mm)
• 20749915002405: ArmourSorb Ray-Cot 3/4" x 3/4" (19 mm x 19 mm)
• 20749915002399: ArmourSorb Ray-Cot 1/2" x 3" (13 mm x 76 mm)
• 20749915002382: ArmourSorb Ray-Cot 1/2" x 1 1/2" (13 mm x 38 mm)
• 20749915002375: ArmourSorb Ray-Cot 1/2" x 1" (13 mm x 25 mm)
• 20749915002351: ArmourSorb Ray-Cot 3/8" x 3" (10 mm x 76 mm)
• 20749915002344: ArmourSorb Ray-Cot 1/4" x 3" (6 mm X 76 mm)