BIOSORB® BGF0505U
GUDID 25051978008429
Gelling Fiber Dressing
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Exudate-absorbent dressing, hydrophilic-gel, sterile| Primary Device ID | 25051978008429 |
| NIH Device Record Key | 137f2b8a-76bf-4f19-88e7-8d4bfd7be51d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOSORB® |
| Version Model Number | BGF0505U |
| Catalog Number | BGF0505U |
| 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 | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051978008422 [Primary] |
| GS1 | 25051978008429 [Package] Contains: 15051978008422 Package: [10 Units] In Commercial Distribution |
FDA Product Code
| NAC | Dressing, Wound, Hydrophilic |
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 [BIOSORB®]
| 25051978008450 | Gelling Fiber Dressing |
| 25051978008443 | Gelling Fiber Dressing |
| 25051978008436 | Gelling Fiber Dressing |
| 25051978008429 | Gelling Fiber Dressing |
Trademark Results [BIOSORB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSORB 88832210 not registered Live/Pending |
Theragun, Inc. 2020-03-12 |
 BIOSORB 87338911 5649908 Live/Registered |
Trans America Product Technology, Inc. 2017-02-16 |
 BIOSORB 86801151 not registered Dead/Abandoned |
Novartis AG 2015-10-27 |
 BIOSORB 86217522 4617375 Live/Registered |
Baker Hughes Incorporated 2014-03-11 |
 BIOSORB 86081856 5114839 Live/Registered |
KCI USA, INC. 2013-10-03 |
 BIOSORB 79041464 not registered Dead/Abandoned |
HERNIAMESH S.R.L. 2007-05-30 |
 BIOSORB 78820726 not registered Dead/Abandoned |
ICON INTERVENTIONAL SYSTEMS, INC. 2006-02-22 |
 BIOSORB 78696644 3219521 Live/Registered |
Aquasol Corporation 2005-08-19 |
 BIOSORB 77947041 not registered Dead/Abandoned |
ICON Medical Corp. 2010-03-01 |
 BIOSORB 77482267 not registered Dead/Abandoned |
BioPharma Scientific, Inc. 2008-05-23 |
 BIOSORB 76291704 2802994 Dead/Cancelled |
Grain Processing Corporation 2001-07-30 |
 BIOSORB 76239878 not registered Dead/Abandoned |
Asian Sources Inc 2001-04-13 |
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