Primary Device ID | 20609271040056 |
NIH Device Record Key | 2fcdc44b-79e2-4f41-8521-f76100c7dc8c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Body Armor® Stirrup Walker |
Version Model Number | BSS0W |
Catalog Number | BSS0W |
Company DUNS | 184231298 |
Company Name | DARCO INTERNATIONAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00609271040052 [Primary] |
GS1 | 10609271040059 [Package] Contains: 00609271040052 Package: Box [4 Units] In Commercial Distribution |
GS1 | 20609271040056 [Package] Contains: 00609271040052 Package: Case [12 Units] In Commercial Distribution |
NOC | Splint, extremity, non-inflatable, external, non-sterile |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-02 |
Device Publish Date | 2023-09-22 |
20609271040391 | Short, pneumatic, gray (x-large) |
10609271040387 | Short, pneumatic, gray (large) |
20609271040377 | Short, pneumatic, gray (medium) |
10609271040363 | Short, pneumatic, gray (small) |
20609271040353 | Short, pneumatic, gray (x-small) |
10609271040349 | Tall, pneumatic, gray (x-large) |
20609271040339 | Tall, pneumatic, gray (large) |
10609271040325 | Tall, pneumatic, gray (medium) |
10609271040318 | Tall, pneumatic, gray (small) |
20609271040308 | Tall, pneumatic, gray (x-small) |
10609271040295 | Short, gray (x-large) |
20609271040285 | Short, gray (large) |
10609271040271 | Short, gray (medium) |
10609271040264 | Short, gray (small) |
20609271040254 | Short, gray (x-small) |
20609271040216 | Tall, gray (small) |
10609271040202 | Tall, gray (x-small) |
20609271040193 | Short, pneumatic, white (x-large) |
20609271040186 | Short, pneumatic, white (large) |
10609271040172 | Short, pneumatic, white (medium) |
20609271040162 | Short, pneumatic, white (small) |
10609271040158 | Short, pneumatic, white (x-small) |
20609271040148 | Tall, pneumatic, white (x-large) |
10609271040134 | Tall, pneumatic, white (large) |
20609271040124 | Tall, pneumatic, white (medium) |
20609271040117 | Tall, pneumatic, white (small) |
20609271040100 | Tall, pneumatic, white (x-small) |
10609271040097 | Short, white (x-large) |
20609271040087 | Short, white (large) |
10609271040073 | Short, white (medium) |
20609271040063 | Short, white (small) |
20609271040056 | Short, white (x-small) |
20609271040018 | Tall, white (small) |
10609271040004 | Tall, white (x-small) |
20609271040247 | Tall, gray (x-large) |
10609271040233 | Tall, gray (large) |
10609271040226 | Tall, gray (medium) |
20609271040049 | Tall, white (x-large) |
10609271040035 | Tall, white (large) |
20609271040025 | Tall, white (medium) |