FDA.reportPublic FDA data

CollaTape®

Primary DI
10381780000273
Brand
CollaTape®
Company
Integra Lifesciences Corporation
Model
0100
Catalog number
0100
Device description
CollaTape® CollaTape ® Absorbable Collagen Wound Dressing, 1in x 3in
Published
2014-09-11
Public version status
Update
Distribution status
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
30381780000277PackageGS14In Commercial Distribution
10381780000273PrimaryGS10
H13301001SecondaryHIBCC0
00381780000276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038178000027730381780000277
1038178000027310381780000273
00381780000276003817800002763817800002760381780000276

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, animal-derivedA collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.

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
10381780000280Integra® Miltex® HeliTape®Integra Lifesciences CorporationLPG2014-09-11
10381780000297Integra® Miltex® HeliTape®Integra Lifesciences CorporationLPG2014-09-11
10381780000303Integra® Miltex® HeliTape®Integra Lifesciences CorporationLPG2014-09-11
10381780000310ORACOTE®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