DEVICE: Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (00381780000191)

Device Identifier (DI) Information

Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
1690-ZZ
In Commercial Distribution
1690-ZZ
Integra Lifesciences Corporation
00381780000191
GS1

1
083171244 *Terms of Use
ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 1/2IN X 1IN, 7MM THICK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
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

[?]
Product Code Product Code Name
LMF Agent, Absorbable Hemostatic, Collagen Based
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P850010 007
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Sterilization

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

[?]
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: 1.27 cm x 2.54 cm x 7.0 mm
Device Size Text, specify: 1/2 in x 1in x 7.0 mm
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Device Record Status

9bfdffa4-df63-40aa-a375-d234fefa1511
July 06, 2018
3
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
10381780000198 18 00381780000191 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
HIBCC M2691690ZZ0
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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