DEVICE: INSTAT* MCH Microfibrillar Collagen Hemostat (10705031003194)

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Device Identifier (DI) Information

INSTAT* MCH Microfibrillar Collagen Hemostat
1984
1984
Integra Lifesciences Corporation
10705031003194
GS1
1
ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Collagen haemostatic agent A sterile, bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LMF Agent, Absorbable Hemostatic, Collagen Based
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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 and humidity
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 0.5 GRAM
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Device Status

In Commercial Distribution
September 11, 2014

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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
30705031003198 3 20705031003191 In Commercial Distribution Case
20705031003191 4 10705031003194 In Commercial Distribution Case
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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