ORACOTE-PKG-10

GUDID 00841336100800

Salvin OraCote Collagen Wound Dressing - Pkg of 10

Salvin Dental Specialties, Inc.

General oral wound dressing, animal-derived

Primary Device ID	00841336100800
NIH Device Record Key	1aa659f6-7374-4be7-a7a8-e109a5eaa9ec
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORACOTE-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
Phone	800-535-6566
Email	orders@salvin.com

Device Dimensions

Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 Millimeter
Width	20 Millimeter
Length	40 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
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	00841336100800 [Primary]
GS1	10841336100807 [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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00841336112056 - Salvin	2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 30x40mm
00841336111929 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material -0.25g (0.54cc) 250-1000 microns
00841336111936 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5g (1.08cc) 250-1000 microns
00841336111943 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns
00841336111950 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 2.0g(4.32cc) 250-1000 microns
00841336111998 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns