ORATAPE® Absorbable Collagen Wound Dressing for Dental Surgery

Primary DI
30381780000338
Brand
ORATAPE® Absorbable Collagen Wound Dressing for Dental Surgery
Company
Integra Lifesciences Corporation
Model
#ORATAPE-PKG-10
Catalog number
#ORATAPE-PKG-10
Device description
SALVIN OraTAPE® Absorbable Collagen Wound Dressing for Dental Surgery, 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
OTC
false
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
30381780000338PackageGS14In Commercial Distribution
10381780000334PrimaryGS10
M268ORATAPEPKG101SecondaryHIBCC0
00381780000337Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038178000033830381780000338
1038178000033410381780000334
00381780000337003817800003373817800003370381780000337

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
083171244
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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