E.M. Adams Company

GUDID 50840200325313

SINGLE INSTRUMENT

E.M. ADAMS, INC.

General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use General-purpose surgical scissors, single-use

• Primary Device ID: 50840200325313
• NIH Device Record Key: 50c611f3-1b88-4499-9cc1-29b3cedd8c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E.M. Adams Company
• Version Model Number: 14-3390-1
• 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: 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: 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
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840200325322 [Primary]
GS1	30840200325326 [Package]; Package: BX [20 Units]; In Commercial Distribution
GS1	50840200325313 [Package]; Contains: 10840200325322; Package: CASE [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K812133

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

[50840200325313]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

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

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