E.M. Adams Company

GUDID 50840200314447

ELBOW SPLINT

E.M. ADAMS, INC.

Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable

• Primary Device ID: 50840200314447
• NIH Device Record Key: 0bf08721-da27-4877-8617-e9f66b66bb44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E.M. Adams Company
• Version Model Number: EP28-0205U-1
• Company DUNS: 001403807
• Company Name: E.M. ADAMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: 772-461-0532
• Email: EMADAMS@EMADAMSCO.COM

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840200314456 [Primary]
GS1	50840200314447 [Package]; Contains: 10840200314456; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971948

FDA Product Code

• FMQ: Restraint, Protective

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: 2022-05-10
• Device Publish Date: 2022-05-02

On-Brand Devices [E.M. Adams Company]

• 50840200314508: ELBOW SPLINT
• 50840200314447: ELBOW SPLINT
• 50840200325313: SINGLE INSTRUMENT