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) |