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
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336100800Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCLPG2020-02-28
00841336100886Salvin 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