DEVICE: PSD gel (00085412531434)

Device Identifier (DI) Information

PSD gel
PSDGEL3PKWTIPS
In Commercial Distribution
PSDGel3pkwTips
SYNOVIS LIFE TECHNOLOGIES, INC.
00085412531434
GS1

1
017415781 *Terms of Use
PSD Gel is prepared from Hydroxypropyl Methyl Cellulose, Propylene Glycol, and water. The PSD Gel is used to bond the Peri-Strips Dry pericardium strips onto the surgical stapler forks until the stapler is positioned and fired.
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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
Staple line-reinforcement strip gel A sterile gelatinous substance designed to be used during staple line buttress (reinforcement) procedures (e.g., lung/bronchus resections, bariatric and small bowel surgery). It is typically applied to the buttress strip material to facilitate rehydration and temporary adherence to the surgical stapler unit prior to the application of the staples and buttress strip to body tissue. It typically consists of a colloidal suspension (hydrogel) applied with an included applicator. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FTM Mesh, surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 room temp 15-30C or 59-86F
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a8cecb0e-4f69-43d8-901f-c5a34c7cd245
March 29, 2018
2
October 05, 2015
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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
50085412531439 3 00085412531434 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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