E.M Adams co, inc.

GUDID 58100013405087

HAND MITT

E.M. ADAMS, INC.

Limb/torso/head restraint, reusable

• Primary Device ID: 58100013405087
• NIH Device Record Key: 44b6ee79-f2aa-486b-b3f1-943815db2879
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E.M Adams co, inc.
• Version Model Number: 40434XL-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
• Device Size Text, specify: 0
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• 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 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	18100013405096 [Primary]
GS1	58100013405087 [Package]; Contains: 18100013405096; Package: Case [12 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

On-Brand Devices [E.M Adams co, inc.]

• 58100013405599: ABDOMINAL BINDER
• 58100013405544: ABDOMINAL BINDER
• 58100013405537: ABDOMINAL BINDER
• 58100013405513: LIMB HOLDER
• 58100013405506: LIMB HOLDER
• 58100013405490: LIMB HOLDER
• 58100013405483: LIMB HOLDER
• 58100013405322: LIMB HOLDER
• 58100013405193: POLY BELT
• 58100013405186: 50" NYLON STRAP-LOCK
• 58100013405179: POLY BELT
• 58100013405162: POLY BELT
• 58100013404851: POLY BELT
• 58100013404783: UNIVERSAL KNEE SPLINT
• 58100013404776: HAND MITT
• 58100013404769: HAND MITT
• 58100013404752: HAND MITT
• 58100013404745: POLY BELT
• 58100013404479: TUFF CUFF
• 58100013404462: TUFF CUFF
• 58100013404400: TUFF CUFF
• 58100013404370: TUFF CUFF
• 58100013404363: TUFF CUFF
• 58100013404356: TUFF CUFF
• 58100013404349: TUFF CUFF
• 58100013404332: TUFF CUFF
• 58100013404325: TUFF CUFF
• 58100013404264: TUFF CUFF
• 58100013404257: TUFF CUFF
• 58100013404226: LIMB HOLDER
• 58100013404219: TUFF CUFF
• 58100013404202: TUFF CUFF
• 58100013404097: TUFF CUFF
• 58100013404080: TUFF CUFF
• 58100013404073: TUFF CUFF
• 58100013404066: TUFF CUFF
• 58100013403793: TUFF CUFF
• 58100013403786: TUFF CUFF
• 58100013403779: TUFF CUFF
• 58100013403762: TUFF CUFF
• 58100013403755: TUFF CUFF
• 58100013403748: TUFF CUFF
• 58100013403731: TUFF CUFF
• 58100013403724: TUFF CUFF
• 58100013403717: TUFF CUFF
• 58100013403441: POLY BELT
• 58100013403434: POLY BELT
• 58100013401409: ABDOMINAL BINDER
• 58100013401393: ABDOMINAL BINDER
• 58100013411835: SAFETY VEST