GuideBlade AMB 1811

GUDID 20860000561918

GuideBlade, non-sterile, intended for inclusion in kits

Ambitus Medical Supplies LLC

Scalpel, single-use

• Primary Device ID: 20860000561918
• NIH Device Record Key: ee88ced3-5190-4af6-aec2-dd3e9a2feafe
• Commercial Distribution Discontinuation: 2023-07-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GuideBlade
• Version Model Number: AMB 1811
• Catalog Number: AMB 1811
• Company DUNS: 117065827
• Company Name: Ambitus Medical Supplies LLC
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com
• Phone: 516-766-3800
• Email: ari@ambitusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000561914 [Primary]
GS1	20860000561918 [Unit of Use]

FDA Product Code

• GDX: Scalpel, One-Piece

Sterilization

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

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

[20860000561918]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [GuideBlade]

• 20860000561918: GuideBlade, non-sterile, intended for inclusion in kits
• 00860000561907: Sterile GuideBlade