TIELLE® LITE MTL301EN

GUDID 25051978003318

Hydropolymer Adhesive Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Wound-nonadherent dressing, absorbent, sterile
Primary Device ID25051978003318
NIH Device Record Keyc95c7ee3-8c94-4ee8-bbc8-22c046a9cdc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTIELLE® LITE
Version Model NumberMTL301EN
Catalog NumberMTL301EN
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

Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 Centimeter
Width11 Centimeter
Length11 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

Device Identifiers

Device Issuing AgencyDevice ID
GS115051978003311 [Primary]
GS125051978003318 [Package]
Contains: 15051978003311
Package: [10 Units]
In Commercial Distribution

FDA Product Code

NACDressing, Wound, Hydrophilic

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® LITE]

25051978005626Hydropolymer Adhesive Dressing
25051978003318Hydropolymer Adhesive Dressing
25051978003301Hydropolymer Adhesive Dressing
25051978000720Hydropolymer Adhesive Dressing
25051978000706Hydropolymer 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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