Wrist Drop w/ U-Cuff Hand Splint WDS01RM

GUDID 00810006682519

Wrist Drop w/ U-Cuff Hand Splint - Medium (Right)

PRIMO INC

Hand/finger splint, single-use

• Primary Device ID: 00810006682519
• NIH Device Record Key: 2654b8ad-46d5-4811-8b70-fb14cbcccf70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wrist Drop w/ U-Cuff Hand Splint
• Version Model Number: WDS01RM
• Catalog Number: WDS01RM
• Company DUNS: 958758146
• Company Name: PRIMO 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: false
• 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	00810006682519 [Primary]

FDA Product Code

• ILH: Splint, Hand, And Components

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: 2019-03-11
• Device Publish Date: 2019-02-27

On-Brand Devices [Wrist Drop w/ U-Cuff Hand Splint]

• 00810006682533: Wrist Drop w/ U-Cuff Hand Splint - XLarge (Right)
• 00810006682526: Wrist Drop w/ U-Cuff Hand Splint - Small (Right)
• 00810006682519: Wrist Drop w/ U-Cuff Hand Splint - Medium (Right)
• 00810006682502: Wrist Drop w/ U-Cuff Hand Splint - Large (Right)
• 00810006682496: Wrist Drop w/ U-Cuff Hand Splint - XLarge (Left)
• 00810006682489: Wrist Drop w/ U-Cuff Hand Splint - Small (Left)
• 00810006682472: Wrist Drop w/ U-Cuff Hand Splint - Medium (Left)
• 00810006682465: Wrist Drop w/ U-Cuff Hand Splint - Large (Left)