ORCA Foam

GUDID 00860008294364

AbsorbaleGelatin Sponge

Orca Products, LLC

Gelatin haemostatic agent

• Primary Device ID: 00860008294364
• NIH Device Record Key: d678d048-ecce-4f3b-a4d5-b69b0ee50ce2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORCA Foam
• Version Model Number: Cube
• Company DUNS: 117716283
• Company Name: Orca Products, LLC
• Device Count: 32
• 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

Customer Support Contacts

• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com
• Phone: 334-803-2370
• Email: cdsdds@me.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008294357 [Primary]
GS1	00860008294364 [Unit of Use]

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: 2023-09-25
• Device Publish Date: 2023-09-15

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