INTEGRA® 3614ES-79I

GUDID 00650551037286

TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT

PMT CORPORATION

Skin-port tissue expander
Primary Device ID00650551037286
NIH Device Record Key438afb5d-f668-49ca-99ed-2d8e6241b5fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRA®
Version Model Number3614ES-79I
Catalog Number3614ES-79I
Company DUNS039576871
Company NamePMT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-626-5463
Emailintl@pmtcorp.com
Phone800-626-5463
Emailintl@pmtcorp.com

Device Dimensions

Width4.5 Centimeter
Width4.5 Centimeter
Width4.5 Centimeter
Width4.5 Centimeter
Width4.5 Centimeter
Width4.5 Centimeter
Width4.5 Centimeter
Width4.5 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100650551037286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCJExpander, Skin, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2016-08-11

On-Brand Devices [INTEGRA®]

00650551037569BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
00650551037552BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
00650551037545BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
00650551037538BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
00650551037521BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
00650551037514BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
00650551037507BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
00650551037491BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
00650551037484BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
00650551037477BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
00650551037460BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
00650551037453BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
00650551037446BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
00650551037439BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
00650551037422BREAST EXPANDER, ANATOMICAL, SMOOTH
00650551037415BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
00650551037408BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
00650551037392BREAST EXPANDER, ANATOMICAL, SMOOTH
00650551037385BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
00650551037378BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
00650551037361BREAST EXPANDER, ANATOMICAL, SMOOTH
00650551037354BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
00650551037347BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
00650551037330BREAST EXPANDER, ANATOMICAL, SMOOTH
00650551037323TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037316TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
00650551037309TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037293TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
00650551037286TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037279TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
00650551037262TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037255TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
00650551037248TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037231TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
00650551037224TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE
00650551037217TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
00650551037200TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037194TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, EDGE PORT
00650551037187TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
00650551037170TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, 2-STAGE
00650551037163TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE
00650551037156TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037149TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
00650551037132TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE
00650551037125TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
00650551037118TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037101TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
00650551037095TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
00650551037088TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
00650551037071TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE

Trademark Results [INTEGRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEGRA
INTEGRA
98465614 not registered Live/Pending
Cleveland-Cliffs Inc.
2024-03-25
INTEGRA
INTEGRA
98382495 not registered Live/Pending
Universal Instruments Corporation
2024-01-30
INTEGRA
INTEGRA
98155011 not registered Live/Pending
Integra Mission Critical, LLC
2023-08-29
INTEGRA
INTEGRA
97870354 not registered Live/Pending
CROWN PACKAGING TECHNOLOGY, INC.
2023-04-03
INTEGRA
INTEGRA
97711737 not registered Live/Pending
Honda Motor Co., Ltd.
2022-12-09
INTEGRA
INTEGRA
97640152 not registered Live/Pending
Integra LifeSciences Corporation
2022-10-20
INTEGRA
INTEGRA
97636638 not registered Live/Pending
POLYSOURCE, INC.
2022-10-18
INTEGRA
INTEGRA
97060638 not registered Live/Pending
Nordson Corporation
2021-10-05
INTEGRA
INTEGRA
90894598 not registered Live/Pending
Honda Motor Co. Ltd.
2021-08-20
INTEGRA
INTEGRA
90880335 not registered Live/Pending
Honda Motor Co. Ltd.
2021-08-12
INTEGRA
INTEGRA
88947894 not registered Live/Pending
Horton Point LLC
2020-06-04
INTEGRA
INTEGRA
88794888 not registered Live/Pending
Interior Design Group
2020-02-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.