ActiSplint with Sensi-Wrap

GUDID 00616784353319

ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs

DYNAREX CORPORATION

Arm splint system, self-moulding

• Primary Device ID: 00616784353319
• NIH Device Record Key: f9e1f5e7-645d-45e4-9c14-1f5061b6b583
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActiSplint with Sensi-Wrap
• Version Model Number: 3533
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 50
• 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: false
• Lot Batch: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784353319 [Unit of Use]
GS1	00616784353333 [Primary]

FDA Product Code

• NOC: Splint, Extremity, Non-Inflatable, External, Non-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: 2021-09-09
• Device Publish Date: 2021-09-01

On-Brand Devices [ActiSplint with Sensi-Wrap]

• 00616784353319: ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage
• 00840117349247: ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage