Exufiber® Ag+

GUDID 07323190152759

Exufiber Ag+ 10x10cm

Mölnlycke Health Care AB

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Primary Device ID	07323190152759
NIH Device Record Key	4bd29bca-56f7-44fe-be8c-18e4037c7c72
Commercial Distribution Status	In Commercial Distribution
Brand Name	Exufiber® Ag+
Version Model Number	603425
Company DUNS	631770658
Company Name	Mölnlycke Health Care AB
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	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Dimensions

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Operating and Storage Conditions

Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius
Storage Environment Temperature	Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07323190152759 [Package] Contains: 07323190152766 Package: [6 Units] Discontinued: 1995-12-31 Not in Commercial Distribution
GS1	07323190152766 [Package] Contains: 07323190159581 Package: [10 Units] Discontinued: 1995-12-31 Not in Commercial Distribution
GS1	07323190159581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160379

FDA Product Code

FRO	Dressing, wound, drug

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-02-04
Device Publish Date	2021-01-27

On-Brand Devices [Exufiber® Ag+]

07323190152759	Exufiber Ag+ 10x10cm
07323190152483	Exufiber Ag+ 0.8x17.7" (2x45cm)
07323190152599	Exufiber Ag+ 4x4.8" (10x12cm)
07323190152711	Exufiber Ag+ 8x12" (20x30cm)
07323190152568	Exufiber Ag+ 2x2" (5x5cm)
07323190152681	Exufiber Ag+ 6x6" (15x15cm)

Trademark Results [Exufiber]

Mark Image Registration \| Serial	Company Trademark Application Date
EXUFIBER 79149018 4810535 Live/Registered	Molnlycke Health Care AB 2014-03-17