18100013403665

GUDID 58100013403656

LIMB HOLDER

E.M. ADAMS, INC.

Limb/torso/head restraint, reusable

• Primary Device ID: 58100013403656
• NIH Device Record Key: b4b8c136-3b17-4861-afed-b5db3a175850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 18100013403665
• Version Model Number: 26-0456-1
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM
• Phone: +1(772)461-0532
• Email: EMADAMS@EMADAMSCO.COM

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18100013403665 [Primary]
GS1	58100013403656 [Package]; Contains: 18100013403665; Package: Case [48 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: 2020-01-08
• Device Publish Date: 2019-12-31

Devices Manufactured by E.M. ADAMS, INC.

• 50840200325580 - E.M. Adams Co Inc: 2023-11-29 SUTURE REMOVAL TRAY
• 50840200325566 - E.M. Adams Co, Inc: 2023-11-27 Laceration Tray
• 50840200301072 - E.M. Adams Co Inc: 2023-11-08 LACERATION TRAY
• 10840200325551 - E.M. Adams Co Inc: 2023-11-08 LACERATION TRAY
• 50840200325528 - E.M. Adams Co, Inc.: 2023-10-30 SINGLE INSTRUMENT
• 50840200325443 - E.M. Adams co, inc.: 2023-06-28 SAFETY VEST
• 50840200325313 - E.M. Adams Company: 2022-08-26 SINGLE INSTRUMENT
• 50840200313525 - E.M. ADAMS CO, INC: 2022-07-25 SAFETY VEST