| Primary Device ID | 00850056665186 |
| NIH Device Record Key | b91ceaaa-289b-4954-ac6f-ee55e2996fcc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORCA Foam |
| Version Model Number | OF-100C |
| Company DUNS | 117716283 |
| Company Name | Orca Products, LLC |
| Device Count | 2 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056665186 [Unit of Use] |
| GS1 | 00850056665193 [Primary] |
| 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 | 2025-03-05 |
| Device Publish Date | 2025-02-25 |
| 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) |