| Primary Device ID | 10850056665244 |
| NIH Device Record Key | 6f7bfb72-dba7-4558-acac-84748ed6dffb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORCA Foam Powder |
| Version Model Number | OF-PS-10 |
| Company DUNS | 117716283 |
| Company Name | Orca Products, LLC |
| Device Count | 6 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056665247 [Primary] |
| GS1 | 10850056665244 [Unit of Use] |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-15 |
| Device Publish Date | 2025-04-07 |
| 00850056665131 | AbsorbaleGelatin Powder |
| 00850056665117 | AbsorbaleGelatin Powder |
| 00850056665094 | AbsorbaleGelatin Powder |
| 10850056665244 | "AbsorbaleGelatin Powder--Pre-filled 1g Syringe " |