DEVICE: Prontosan® (04046964295881)

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Device Identifier (DI) Information

Prontosan®
400560
400560
B. BRAUN MEDICAL INC.
04046964295881
GS1
20
Prontosan® Wound Gel, 30 mL Bottle
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Wound hydrogel dressing, sterile, antimicrobial A 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 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, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FRO Dressing, wound, drug
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: AVOID EXCESSIVE HEAT.
Special Storage Condition, Specify: DO NOT REFRIGERATE OR FREEZE.
Special Storage Condition, Specify: STORE AT ROOM TEMPERATURE.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Volume : 30.000 ML
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 04046964295874 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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