Dale Bendable Armboard 650

GUDID H84106501

Dale Bendable Armboard, Large, 9" x 3.5"

DALE MEDICAL PRODUCTS, INC.

Armboard, reusable

• Primary Device ID: H84106501
• NIH Device Record Key: 699e7d1e-0aa9-476f-9354-6911a7a74dc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dale Bendable Armboard
• Version Model Number: 650
• Catalog Number: 650
• Company DUNS: 001061233
• Company Name: DALE MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817612020285 [Primary]
GS1	00817612020292 [Package]; Contains: 00817612020285; Package: Box [10 Units]; In Commercial Distribution
HIBCC	H84106501 [Previous]
HIBCC	H84106502 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• FYH: Splint, Extremity, Noninflatable, External, Sterile

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: 2018-10-01
• Device Publish Date: 2018-08-29

On-Brand Devices [Dale Bendable Armboard]

• 00817612020353: Dale Bendable Armboard, X-Small, 4.25" x 1"
• H84106521: Dale Bendable Armboard, Small, 4.5" x 1.75"
• H84106511: Dale Bendable Armboard, Medium, 5.38" x 2.5"
• H84106501: Dale Bendable Armboard, Large, 9" x 3.5"
• H84106532: Dale Bendable Armboard, X-Small, 4.25" x 1"
• H84106522: Dale Bendable Armboard, Small, 4.5" x 1.75"
• H84106512: Dale Bendable Armboard, Medium, 5.38" x 2.5"