BIOSORB® BGF1515U

GUDID 25051978008443

Gelling Fiber Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Exudate-absorbent dressing, hydrophilic-gel, sterile
Primary Device ID25051978008443
NIH Device Record Keyfbc18fcb-a396-41d4-b260-4981e95c5551
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOSORB®
Version Model NumberBGF1515U
Catalog NumberBGF1515U
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115051978008446 [Primary]
GS125051978008443 [Package]
Contains: 15051978008446
Package: [5 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 [BIOSORB®]

25051978008450Gelling Fiber Dressing
25051978008443Gelling Fiber Dressing
25051978008436Gelling Fiber Dressing
25051978008429Gelling Fiber Dressing

Trademark Results [BIOSORB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOSORB
BIOSORB
88832210 not registered Live/Pending
Theragun, Inc.
2020-03-12
BIOSORB
BIOSORB
87338911 5649908 Live/Registered
Trans America Product Technology, Inc.
2017-02-16
BIOSORB
BIOSORB
86801151 not registered Dead/Abandoned
Novartis AG
2015-10-27
BIOSORB
BIOSORB
86217522 4617375 Live/Registered
Baker Hughes Incorporated
2014-03-11
BIOSORB
BIOSORB
86081856 5114839 Live/Registered
KCI USA, INC.
2013-10-03
BIOSORB
BIOSORB
79041464 not registered Dead/Abandoned
HERNIAMESH S.R.L.
2007-05-30
BIOSORB
BIOSORB
78820726 not registered Dead/Abandoned
ICON INTERVENTIONAL SYSTEMS, INC.
2006-02-22
BIOSORB
BIOSORB
78696644 3219521 Live/Registered
Aquasol Corporation
2005-08-19
BIOSORB
BIOSORB
77947041 not registered Dead/Abandoned
ICON Medical Corp.
2010-03-01
BIOSORB
BIOSORB
77482267 not registered Dead/Abandoned
BioPharma Scientific, Inc.
2008-05-23
BIOSORB
BIOSORB
76291704 2802994 Dead/Cancelled
Grain Processing Corporation
2001-07-30
BIOSORB
BIOSORB
76239878 not registered Dead/Abandoned
Asian Sources Inc
2001-04-13

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