AQUACEL AG EXTRA 420678

GUDID 00768455127450

AQUACEL AG EXTRA 15X15CM(1X5PK) STER NAI

CONVATEC, PURCHASING DEPARTMENT

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Primary Device ID	00768455127450
NIH Device Record Key	1eab060a-116b-4e4c-aff7-a649ab0c2581
Commercial Distribution Status	In Commercial Distribution
Brand Name	AQUACEL AG EXTRA
Version Model Number	420678
Catalog Number	420678
Company DUNS	809784593
Company Name	CONVATEC, PURCHASING DEPARTMENT
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	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
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	15 Centimeter
Length	15 Centimeter
Length	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter
Width	15 Centimeter
Length	15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455127450 [Primary]
GS1	00768455127467 [Package] Package: Carton [5 Units] In Commercial Distribution
GS1	10768455127464 [Package] Contains: 00768455127467 Package: Carton [20 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121275

FDA Product Code

FRO	Dressing, Wound, Drug

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-08-22

On-Brand Devices [AQUACEL AG EXTRA]

00768455127481	AQUACEL AG EXTRA 20X30CM(1X5PK) STER NAI
00768455127450	AQUACEL AG EXTRA 15X15CM(1X5PK) STER NAI
00768455127436	AQUACEL AG EXTRA 10X12CM(1X10PK)STER NAI
00768455127405	AQUACEL AG EXTRA 10X10CM(1X10PK)STER NAI
00768455127375	AQUACEL AG EXTRA 5X5CM(1X10PK) STER NAI