Dale Strapless Bendable Armboard 550

GUDID 00817612020964

Dale Strapless Bendable Armboard, Large, 9" x 3.5"

DALE MEDICAL PRODUCTS, INC.

Arm procedure positioner, single-use

• Primary Device ID: 00817612020964
• NIH Device Record Key: d9b07ff9-31b3-4ca0-b15e-6665d35bdfcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dale Strapless Bendable Armboard
• Version Model Number: 550
• Catalog Number: 550
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place
• Special Storage Condition, Specify: Between 0 and 0 *Cool Dry Place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817612020964 [Package]; Contains: 00817612020971; Package: Box [10 Units]; In Commercial Distribution
GS1	00817612020971 [Primary]

FDA Product Code

• FYH: Splint, Extremity, Noninflatable, External, Sterile
• HEF: Binder, Breast

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: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [Dale Strapless Bendable Armboard]

• 00817612021015: Dale Strapless Bendable Armboard, Small, 4.5" x 1.75"
• 00817612020995: Dale Strapless Bendable Armboard, Medium, 5.38" x 2.5"
• 00817612020964: Dale Strapless Bendable Armboard, Large, 9" x 3.5"