DEVICE: SURGICEL SNoW (10705031063594)

Device Identifier (DI) Information

SURGICEL SNoW
2082
In Commercial Distribution
2082
ETHICON, LLC
10705031063594
GS1

1
829465157 *Terms of Use
oxidized regenerated cellulose; Structured Non-Woven Material
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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
Surgical plant polysaccharide haemostatic agent A sterile, bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended to be applied to wounds during surgical procedures (e.g., open surgery, laparoscopy, dental surgery) to facilitate local haemostasis; it may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LMG Agent, absorbable hemostatic, non-collagen based
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
N12159 032
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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: Store at controlled room temperature
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do Not Resterilize
Special Storage Condition, Specify: Do not use if package is damaged
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b33dbec4-586a-43cf-b6ee-afa36c8e9d46
September 24, 2018
5
September 20, 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
20705031063591 10 10705031063594 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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