Body Armor® Stirrup Walker BPS4W

GUDID 20609271040193

Short, pneumatic, white (x-large)

DARCO INTERNATIONAL, INC.

Ankle/foot orthosis

• Primary Device ID: 20609271040193
• NIH Device Record Key: 588205d3-0df7-4dd0-a4e2-f00f3253a5c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Armor® Stirrup Walker
• Version Model Number: BPS4W
• Catalog Number: BPS4W
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00609271040199 [Primary]
GS1	10609271040196 [Package]; Contains: 00609271040199; Package: Box [4 Units]; In Commercial Distribution
GS1	20609271040193 [Package]; Contains: 00609271040199; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• FZF: SPLINT, EXTREMITY, INFLATABLE, EXTERNAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [Body Armor® Stirrup Walker]

• 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)