ORATAPE-PKG-10

GUDID 00841336100893

Salvin OraTape Collagen Wound Dressing - Pkg of 10

Salvin Dental Specialties, Inc.

General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived

Primary Device ID	00841336100893
NIH Device Record Key	0fa89a1f-fcf2-4880-8ee3-38c5fd32d40e
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORATAPE-PKG-10
Version Model Number	REV7/10
Company DUNS	113344790
Company Name	Salvin Dental Specialties, 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	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com
Phone	800-535-6566
Email	orders@salvin.com

Device Dimensions

Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter
Width	25 Millimeter
Length	75 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841336100893 [Primary]
GS1	10841336100890 [Package] Package: Inner Pack [10 Units] In Commercial Distribution

FDA Product Code

KGN	Wound Dressing With Animal-Derived Material(S)
LPG	Material, Dressing, Surgical, Polylactic Acid

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	2020-03-09
Device Publish Date	2020-02-28

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