Ray-Cot

GUDID 20749915000791

Ray-Cot 3/8" x 3"

AMERICAN SURGICAL COMPANY, LLC

Neurosurgical sponge

• Primary Device ID: 20749915000791
• NIH Device Record Key: f21dc2cd-6ebe-4690-aad4-fc53ad53d9e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ray-Cot
• Version Model Number: 60-05
• Company DUNS: 151054954
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Device Count: 20
• 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	10749915000794 [Unit of Use]
GS1	20749915000791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902921

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: 2016-06-13

On-Brand Devices [Ray-Cot]

• 30749915000903: Ray-Cot 1" x 1"
• 20749915001095: Ray-Cot 1.5" x 6"
• 20749915001088: Ray-Cot 3.5" x 6"
• 20749915001071: Ray-Cot 3" x 6"
• 20749915001064: Ray-Cot 2" x 6"
• 20749915001057: Ray-Cot 1" x 6" Strung Strips
• 20749915001040: Ray-Cot 1" x 6"
• 20749915001033: Ray-Cot 3/4" x 6"
• 20749915001026: Ray-Cot 1/2" x 6" Strung Strips
• 20749915001019: Ray-Cot 1/2" x 6"
• 20749915001002: Ray-Cot 1/4" x 6"
• 20749915000999: Ray-Cot 1/8" x 6"
• 20749915000982: Ray-Cot 1/2" x 2"
• 20749915000975: Ray-Cot 1.5" x 3"
• 20749915000968: Ray-Cot 1/4" x 1.5"
• 20749915000951: Ray-Cot 3" x 3"
• 20749915000944: Ray-Cot 1.5" x 1.5"
• 20749915000920: Ray-Cot 1" x 3"
• 20749915000883: Ray-Cot 3/4" x 3/4"
• 20749915000869: Ray-Cot 1/2" x 3"
• 20749915000845: Ray-Cot 1/2" x 1.5"
• 20749915000821: Ray-Cot 1/2" x 1"
• 20749915000807: Ray-Cot 1/2" x 1/2"
• 20749915000791: Ray-Cot 3/8" x 3"
• 20749915000784: Ray-Cot 1/4" x 3"
• 20749915000777: Ray-Cot 1/4" x 1/4"