Home GUDID 30381780000338
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
Product Codes# Code, Name table Code Name LPG Material, Dressing, Surgical, Polylactic Acid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LPG Material, Dressing, Surgical, Polylactic Acid Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30381780000338 Package GS1 4 In Commercial Distribution 10381780000334 Primary GS1 0 M268ORATAPEPKG101 Secondary HIBCC 0 00381780000337 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30381780000338 30381780000338 10381780000334 10381780000334 00381780000337 00381780000337 381780000337 0381780000337
GMDN Terms# Term, Definition table Term Definition Collagen wound matrix dressing A 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 Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Avoid excessive heat and humidity
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841336100800 Salvin Dental Specialties SALVIN DENTAL SPECIALTIES, LLC LPG 2020-02-28 00841336100886 Salvin Dental Specialties SALVIN DENTAL SPECIALTIES, LLC LPG 2020-02-28 00841336100893 Salvin Dental Specialties SALVIN DENTAL SPECIALTIES, LLC LPG 2020-02-28 10381780490012 creos™ Integra Lifesciences Corporation LPG 2018-09-28 10381780490029 creos™ Integra Lifesciences Corporation LPG 2018-09-28 10381780490036 creos™ Integra Lifesciences Corporation LPG 2018-09-28 30381780490030 N/A Integra Lifesciences Corporation LPG 2018-09-28 30381780490023 N/A Integra Lifesciences Corporation LPG 2018-09-28 30381780490016 N/A Integra Lifesciences Corporation LPG 2018-09-28 10381780000259 CollaPlug® Integra Lifesciences Corporation LPG 2014-09-11 10381780000266 CollaCote® Integra Lifesciences Corporation LPG 2014-09-11 10381780000273 CollaTape® Integra Lifesciences Corporation LPG 2014-09-11 10381780000280 Integra® Miltex® HeliTape® Integra Lifesciences Corporation LPG 2014-09-11 10381780000297 Integra® Miltex® HeliTape® Integra Lifesciences Corporation LPG 2014-09-11 10381780000303 Integra® Miltex® HeliTape® Integra Lifesciences Corporation LPG 2014-09-11 10381780000310 ORACOTE® Integra Lifesciences Corporation LPG 2014-09-11 10381780000327 ORAPLUG® Integra Lifesciences Corporation LPG 2014-09-11 10381780000334 ORATAPE® Integra Lifesciences Corporation LPG 2014-09-11 30381780000253 CollaPlug® Absorbable Collagen Wound Dressing for Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11 30381780000260 CollaCote® Absorbable Collagen Wound Dressing for Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11 30381780000277 CollaTape® Absorbable Collagen Wound Dressing for Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11 30381780000284 HeliTape ® ABSORBABLE COLLAGEN Wound Dressing for Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11 30381780000291 HeliCote ® ABSORBABLE COLLAGEN Wound Dressing For Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11 30381780000307 HeliPlug ® ABSORBABLE COLLAGEN Wound Dressing For Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11 30381780000314 ORACOTE® Absorbable Collagen Wound Dressing for Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11 30381780000321 ORAPLUG® Absorbable Collagen Wound Dressing for Dental Surgery Integra Lifesciences Corporation LPG 2014-09-11