| 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 | 
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | |
| Phone | 334-803-2370 | 
| cdsdds@me.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00860008294357 [Primary] | 
| GS1 | 00860008294364 [Unit of Use] | 
| LYA | Splint, Intranasal Septal | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-09-25 | 
| Device Publish Date | 2023-09-15 | 
| 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 | 
| 00850056665186 | AbsorbaleGelatin Sponge (125mmx80mmx2mm) | 
| 00850056665216 | AbsorbaleGelatin Sponge (80mm x 30mm cylinder) |