N/A WD62201

GUDID 30381780490023

creos™ xenocote Absorbable Collagen Wound Dressing for Dental Surgery

Integra Lifesciences Corporation

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 ID30381780490023
NIH Device Record Key0be49e0a-2a74-4394-9a70-310671034b7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberWD62201
Catalog NumberWD62201
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.

Device Identifiers

Device Issuing AgencyDevice ID
GS100381780490022 [Unit of Use]
GS110381780490029 [Primary]
GS130381780490023 [Package]
Contains: 10381780490029
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

LPGMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-07
Device Publish Date2018-09-28

On-Brand Devices [N/A]

30381780490016creos™ xenoplug Absorbable Collagen Wound Dressing for Dental Surgery
30381780490023creos™ xenocote Absorbable Collagen Wound Dressing for Dental Surgery
30381780490030creos™ xenotape Absorbable Collagen Wound Dressing for Dental Surgery
10381780211082Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrospinal
10381780071273Multi-Purpose Valve, Model: High Pressure 95-150mm H20 closing pressure

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