FDA.reportPublic FDA data

Prontosan®

Primary DI
04046964295881
Brand
Prontosan®
Company
B. BRAUN MEDICAL INC.
Model
400560
Catalog number
400560
Device description
Prontosan® Wound Gel, 30 mL Bottle
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964295881PrimaryGS10
04046964295874Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964295881040469642958814046964295881
04046964295874040469642958744046964295874

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, sterile, antimicrobialA sterile wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing (e.g., by maintaining a moist wound environment); it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, chitosan, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00AVOID EXCESSIVE HEAT
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00DO NOT REFRIGERATE
Special Storage Condition, Specify00DO NOT REFRIGERATE OR FREEZE.
Special Storage Condition, Specify00Store at room temp
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
20
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955850822Omnifix®4616025V-024616025V-022026-03-08
04046963452131Omnifix™4616308F-024616308F-022016-09-23
04046964291647CONTIPLEX®3316763316762016-09-23
04046964291807CONTIPLEX®3321293321292016-09-23
04046964715280CONTIPLEX®3317623317622016-09-23
04046964315954Design Options®5554845554842016-09-23
04046964989742Design Options®5521175521172016-10-24
04046955582969Perfusor®8713330-998713330-992026-06-07
04046955862634Design Options®5522035522032026-06-01
04046955966264Design Options®5522075522072026-06-01
04046964177347Perifix®3320873320872016-09-23
04046964178900Perifix®3322643322642016-09-23
04046955672370Design Options®5606805606802026-05-24
04046955900268Design Options®5517695517692026-05-14
04046964308024Design Options®5517695517692016-09-23
04045928020392Design Options®5521235521232026-05-11
04045928020699Design Options®5521795521792026-05-11
04046955803125Clik-Fix®LLS-1021BLLS-1021B2023-01-06
04046955803163Clik-Fix®LLS-1024BLLS-1024B2023-01-06
04046955803194Clik-Fix®NPS-1006BNPS-1006B2022-12-22

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