ORCA Foam

GUDID 00860003109977

AbsorbaleGelatin Sponge

Orca Products, LLC

Gelatin haemostatic agent

• Primary Device ID: 00860003109977
• NIH Device Record Key: 8e55058e-4f1b-4d5a-83a0-49859b1beb57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORCA Foam
• Version Model Number: Size 12/7
• Company DUNS: 117716283
• Company Name: Orca Products, LLC
• Device Count: 10
• 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: true
• Manufacturing Date: true
• 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	00860003109977 [Unit of Use]
GS1	01086000310997 [Primary]
GS1	10860003109974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060878

FDA Product Code

• LYA: Splint, Intranasal Septal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-04
• Device Publish Date: 2022-02-24

On-Brand Devices [ORCA Foam]

• 10860003109912: AbsorbaleGelatin Sponge
• 00860008294302: AbsorbaleGelatin Sponge
• 00860003109991: AbsorbaleGelatin Sponge
• 00860003109984: AbsorbaleGelatin Sponge
• 00860003109977: AbsorbaleGelatin Sponge
• 00860008294340: AbsorbaleGelatin Sponge
• 00860008294371: AbsorbaleGelatin Sponge
• 00860008294364: AbsorbaleGelatin Sponge
• 00850056665018: AbsorbaleGelatin Sponge
• 00860008294395: AbsorbaleGelatin Sponge