HemaDerm ENT0001-2

GUDID 10801741044080

ENT Kit with HemaDerm Topical Hemostat

Davol Inc.

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• Primary Device ID: 10801741044080
• NIH Device Record Key: a3d80ec3-90cb-4da2-ad1f-d4d7fda20223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemaDerm
• Version Model Number: ENT0001-2
• Catalog Number: ENT0001-2
• Company DUNS: 001191048
• Company Name: Davol 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com

Device Dimensions

• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741044083 [Primary]
GS1	10801741044080 [Package]; Contains: 00801741044083; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033666

FDA Product Code

• NHB: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-17
• Device Publish Date: 2023-10-09

Devices Manufactured by Davol Inc.

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• 00801741200779 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Medium, Right, 3" x 5", 8 x 13 cm
• 00801741200786 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Large, Right, 4” x 6”, 10 x 16 cm
• 00801741200793 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, XL, Right, 5” x 7”, 12 x 17 cm