ORCA Foam

GUDID 00860003109991

AbsorbaleGelatin Sponge

Orca Products, LLC

Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent Gelatin haemostatic agent

• Primary Device ID: 00860003109991
• NIH Device Record Key: 30bc6591-9055-4c0f-b045-2af27756b041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORCA Foam
• Version Model Number: Sze 100
• Company DUNS: 117716283
• Company Name: Orca Products, LLC
• Device Count: 4
• 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	00860003109991 [Unit of Use]
GS1	10860003109998 [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