FDA.reportPublic FDA data

ORACOTE®

Primary DI
10381780000310
Brand
ORACOTE®
Company
Integra Lifesciences Corporation
Model
#ORACOTE-PKG-10
Catalog number
#ORACOTE-PKG-10
Device description
SALVIN OraCOTE® Absorbable Collagen Wound Dressing for Dental Surgery, 3/4in x 1 1/2in
Published
2014-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPGMaterial, Dressing, Surgical, Polylactic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPGMaterial, Dressing, Surgical, Polylactic AcidUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780000314PackageGS14Not in Commercial Distribution
10381780000310PrimaryGS10
M268ORACOTEPKG101SecondaryHIBCC0
00381780000313Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038178000031430381780000314
1038178000031010381780000310
00381780000313003817800003133817800003130381780000313

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat and humidity

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780112075Integra OS™IOS10125IOS101252015-09-23
10381780112082Integra OS™IOS10155IOS101552015-09-23
10381780112426Trel-XC PasteTXCPA01TXCPA012015-09-22
10381780112433Trel-XC PasteTXCPA03TXCPA032015-09-22
10381780112440Trel-XC PasteTXCPA08TXCPA082015-09-22
10381780112457Trel-XC PuttyTXCPY05TXCPY052015-09-22
10381780112464Trel-XC PuttyTXCPY10TXCPY102015-09-22
10381780112471Trel-X PuttyTXP05TXP052015-09-22
10381780112488Trel-X PuttyTXP10TXP102015-09-22
10381780112495Trel-X GelTXG01TXG012015-09-22
10381780112501Trel-X GelTXG05TXG052015-09-22
10381780112518Trel X-Press 100XPRES110XPRES1102015-09-22
10381780112525Trel X-Press 100XPRES105XPRES1052015-09-22
10381780112532Trel X-Press 100XPRES125XPRES1252015-09-22
10381780112556Trel X-Press 300XPRES305XPRES3052015-09-25
10381780112563Trel X-Press 300XPRES325XPRES3252015-09-25
10381780112570Trel XPress 300CXPres3c10XPres3c102015-09-25
10381780114338Collage Osteoconductive Scaffold - Putty7100057100052015-09-22
10381780114345Collage Osteoconductive Scaffold - Putty7100107100102015-09-22
10381780114352Collage Osteoconductive Scaffold - Putty7100157100152015-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336100800Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCLPG2020-02-28
00841336100893Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCLPG2020-02-28
10381780490012creos™Integra Lifesciences CorporationLPG2018-09-28
10381780490029creos™Integra Lifesciences CorporationLPG2018-09-28
10381780490036creos™Integra Lifesciences CorporationLPG2018-09-28
30381780490030N/AIntegra Lifesciences CorporationLPG2018-09-28
30381780490023N/AIntegra Lifesciences CorporationLPG2018-09-28
30381780490016N/AIntegra Lifesciences CorporationLPG2018-09-28
10381780000259CollaPlug®Integra Lifesciences CorporationLPG2014-09-11
10381780000266CollaCote®Integra Lifesciences CorporationLPG2014-09-11
10381780000273CollaTape®Integra Lifesciences CorporationLPG2014-09-11
10381780000280Integra® Miltex® HeliTape®Integra Lifesciences CorporationLPG2014-09-11
10381780000297Integra® Miltex® HeliTape®Integra Lifesciences CorporationLPG2014-09-11
10381780000303Integra® Miltex® HeliTape®Integra Lifesciences CorporationLPG2014-09-11
10381780000327ORAPLUG®Integra Lifesciences CorporationLPG2014-09-11
10381780000334ORATAPE®Integra Lifesciences CorporationLPG2014-09-11
30381780000253CollaPlug® Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000260CollaCote® Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000277CollaTape® Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000284HeliTape ® ABSORBABLE COLLAGEN Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000291HeliCote ® ABSORBABLE COLLAGEN Wound Dressing For Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000307HeliPlug ® ABSORBABLE COLLAGEN Wound Dressing For Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000314ORACOTE® Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000321ORAPLUG® Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11
30381780000338ORATAPE® Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11