BioStrip BioHorizons - 25mm x 75mm x 1mm BH2210

GUDID 00813909010267

Collagen wound dressing

NOVABONE PRODUCTS, LLC

General oral wound dressing, animal-derived

Primary Device ID	00813909010267
NIH Device Record Key	1ade6c7a-d0cf-4e44-9232-36f369450605
Commercial Distribution Status	In Commercial Distribution
Brand Name	BioStrip BioHorizons - 25mm x 75mm x 1mm
Version Model Number	BH2210
Catalog Number	BH2210
Company DUNS	828813290
Company Name	NOVABONE PRODUCTS, LLC
Device Count	10
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

Device Dimensions

Length	75 Millimeter
Length	75 Millimeter
Length	75 Millimeter
Length	75 Millimeter
Length	75 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Depth	1 Millimeter
Length	75 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909010267 [Primary]
GS1	00813909010540 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142712

FDA Product Code

KGN	Dressing, Wound, Collagen

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-09-14

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