INTEGRA

GUDID 00650551147893

INTEGRA, ANATOMICAL TEARDROP SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER

PMT CORPORATION

Skin-port tissue expander

Primary Device ID	00650551147893
NIH Device Record Key	cadfae0e-c0fa-47ba-944e-ff35e1f7fd46
Commercial Distribution Status	In Commercial Distribution
Brand Name	INTEGRA
Version Model Number	3612-63A-IR
Company DUNS	039576871
Company Name	PMT CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter
Total Volume	650 Milliliter
Length	12.5 Centimeter
Width	13.5 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment Temperature	Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551147893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K845036

FDA Product Code

LCJ	Expander, Skin, Inflatable

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-05-26
Device Publish Date	2020-05-18

On-Brand Devices [INTEGRA]

00650551149460	TE CRESCENT, SMOOTH SURFACE, TWO STAGE, REMOTE PORT, 4X6CM, 97CC FILL, 6CM PROJECTION
00650551148326	INTEGRA RECTANGLE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551148319	INTEGRA, IRREGULAR CRESCENT SHAPE, SMOOTH SURFACE, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551148302	INTEGRA, CRESCENT SHAPE, SMOOTH SURFACE, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551148296	INTEGRA, IRREGULAR SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551147930	INTEGRA, ROUND BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551147923	INTEGRA, ROUND BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551147893	INTEGRA, ANATOMICAL TEARDROP SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
00650551147886	INTEGRA, LOW HEIGHT BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
00650551147824	INTEGRA, CURVE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS
00650551147169	INTEGRA, BE CRESCENT SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER WITH SUTURE TABS
00650551147152	INTEGRA, BE CRESCENT SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER WITH SUTURE TABS
00650551147145	INTEGRA, BE CRESCENT SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER WITH SUTURE TABS
00650551147053	INTEGRA, IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS
00650551147046	INTEGRA, RECTANGLE SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS
00650551147039	INTEGRA, IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551146957	INTEGRA, ANATOMICAL SHAPE, SMOOTH, REMOTE PORT TISSUE EXPANDER
00650551146773	INTEGRA, LOW HEIGHT BE SHAPE, ENHANCED SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
00650551146766	INTEGRA, HOW HEIGHT BE SHAPE, ENHANCED SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
00650551146759	INTEGRA, ROUND SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER SUTURE TAB
00650551146612	INTEGRA, RECTANGE SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146605	INTEGRA, RECTANGE SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551146599	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146582	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146575	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146568	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146551	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146544	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146537	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146520	INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551146476	INTEGRA, RECTANGLE SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551144427	INTEGRA, RECTANGLE SHAPE, SMOOTH, 2-STAGE, MICRO REMOTE PORT TISSUE EXPANDER
00650551144410	INTEGRA ROUND SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
00650551144366	INTEGRA ROUND SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551144267	INTEGRA RECTANGE SHAPE, SMOOTH, 2-STAGE, REMOTE PORT, SUTURE TAB TISSUE EXPANDER
00650551144236	INTEGRA IRREGULAR SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551144229	INTEGRA IRREGULAR SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
00650551144199	INTEGRA CYLINDER SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT, SUTURE TABS, TISSUE EXPANDER
00650551144113	INTEGRA CURVE SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551144106	INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551144090	INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551144083	INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551144076	INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551144069	INTEGRA, IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
00650551023302	INTEGRA, WB OVAL SHAPE, ENHANCED SURFACE, 2-STAGE, INTERNAL PORT TISSUE EXPANDER
00650551149934	INTEGRA, TEARDROP SHAPE, SMOOTH SURFACE, 2-STAGE, INTERNAL PORT WITH SUTURE TABS
00650551149927	INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT WITH SUTURE TABS
00650551149910	INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT
00650551149859	INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT
00650551149828	INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT WITH SUTURE TABS

Trademark Results [INTEGRA]

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