TIELLE® PLUS MTP505

GUDID 25051978000867

Hydropolymer Adhesive Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Exudate-absorbent dressing, non-gel
Primary Device ID25051978000867
NIH Device Record Keya2c68e90-fe7b-4dd0-96dd-6eea0dd8b316
Commercial Distribution StatusIn Commercial Distribution
Brand NameTIELLE® PLUS
Version Model NumberMTP505
Catalog NumberMTP505
Company DUNS211352227
Company NameSYSTAGENIX WOUND MANAGEMENT, LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115051978000860 [Primary]
GS125051978000867 [Package]
Contains: 15051978000860
Package: [10 Units]
In Commercial Distribution

FDA Product Code

NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-02
Device Publish Date2019-09-24

On-Brand Devices [TIELLE® PLUS]

25051978000867Hydropolymer Adhesive Dressing
25051978000843Hydropolymer Adhesive Dressing
25051978000829Hydropolymer Adhesive Dressing

Trademark Results [TIELLE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TIELLE
TIELLE
74688002 2022613 Live/Registered
KCI USA, INC.
1995-06-14

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