FDA.reportPublic FDA data

N/A

Primary DI
30381780490016
Brand
N/A
Company
Integra Lifesciences Corporation
Model
WD62202
Catalog number
WD62202
Device description
creos™ xenoplug Absorbable Collagen Wound Dressing for Dental Surgery
Published
2018-09-28
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
30381780490016PackageGS14In Commercial Distribution
10381780490036PrimaryGS10
00381780490039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038178049001630381780490016
1038178049003610381780490036
00381780490039003817804900393817804900390381780490039

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, Specify00The product should be stored at room temperature. Avoid 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
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
30381780000338ORATAPE® Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Lifesciences CorporationLPG2014-09-11