ORATAPE® Absorbable Collagen Wound Dressing for Dental Surgery #ORATAPE-PKG-10

GUDID 30381780000338

SALVIN OraTAPE® Absorbable Collagen Wound Dressing for Dental Surgery, 1in x 3in

Integra Lifesciences Corporation

Collagen wound matrix dressing
Primary Device ID30381780000338
NIH Device Record Keyea33a9c6-a2d8-4381-8bad-955aa9b32237
Commercial Distribution StatusIn Commercial Distribution
Brand NameORATAPE® Absorbable Collagen Wound Dressing for Dental Surgery
Version Model Number#ORATAPE-PKG-10
Catalog Number#ORATAPE-PKG-10
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
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Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
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Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
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Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
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Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
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Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
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Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat and humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100381780000337 [Unit of Use]
GS110381780000334 [Primary]
GS130381780000338 [Package]
Contains: 10381780000334
Package: Case [4 Units]
In Commercial Distribution
HIBCCM268ORATAPEPKG101 [Secondary]

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 Number5
Public Version Date2020-05-06
Device Publish Date2014-09-11

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10381780538158 - Omni-Tract®2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, .75in x 2in (1.9cm x 5.1cm)
10381780538165 - Omni-Tract®2024-07-18 Omni-Tract® Malleable Swivel Retractor, 1in x 3in (2.5cm x 7.6cm) Mini
10381780538172 - Omni-Tract®2024-07-18 Omni-Tract® Medial Retractor, 1.5in x 3.5in (3.8cm x 8.9cm)
10381780538189 - Omni-Tract®2024-07-18 Omni-Tract® Meyerding Retractor, Blunt, 1in x 3in (2.5cm x 7.6cm)

Trademark Results [ORATAPE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORATAPE
ORATAPE
77908981 3938870 Live/Registered
Salvin Dental Specialties, Inc.
2010-01-11

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