DEVICE: Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (00381780000207)
Device Identifier (DI) Information
Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
3410-ZX
In Commercial Distribution
3410-ZX
Integra Lifesciences Corporation
3410-ZX
In Commercial Distribution
3410-ZX
Integra Lifesciences Corporation
ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 3IN X 4IN, 5MM THICK
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47201 | Collagen haemostatic agent, non-antimicrobial |
A 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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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LMF | Agent, Absorbable Hemostatic, Collagen Based |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P850010 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Avoid excessive heat and humidity |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 7.5 cm x 10 cm x 5.0 mm |
Device Size Text, specify: 3 in x 4 in x 5.0 mm |
Device Record Status
5bdb799d-5d44-46d7-8378-a1d5ad5cdd69
September 22, 2020
5
September 11, 2014
September 22, 2020
5
September 11, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10381780000204 | 10 | 00381780000207 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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HIBCC | M2693410ZX0 |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined