TIELLE® NON ADHESIVE TLN1212EN

GUDID 25051978008290

Non Adhesive Hydropolymer Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Exudate-absorbent dressing, non-gel

Primary Device ID	25051978008290
NIH Device Record Key	96fc2795-0a44-4595-9172-55bcdc492fea
Commercial Distribution Status	In Commercial Distribution
Brand Name	TIELLE® NON ADHESIVE
Version Model Number	TLN1212EN
Catalog Number	TLN1212EN
Company DUNS	211352227
Company Name	SYSTAGENIX WOUND MANAGEMENT, LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter
Width	12.5 Centimeter
Length	12.5 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051978008293 [Primary]
GS1	25051978008290 [Package] Contains: 15051978008293 Package: [10 Units] In Commercial Distribution

FDA Product Code

NAD	Dressing, Wound, Occlusive

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	2019-10-02
Device Publish Date	2019-09-24

On-Brand Devices [TIELLE® NON ADHESIVE]

25051978008290	Non Adhesive Hydropolymer Dressing
25051978004735	Non Adhesive Hydropolymer Dressing
25051978004704	Non Adhesive Hydropolymer Dressing
25051978004667	Non Adhesive Hydropolymer Dressing
25051978004605	Non Adhesive Hydropolymer Dressing
25051978004575	Non Adhesive Hydropolymer Dressing

Trademark Results [TIELLE]

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