DEVICE: Gelfoam Plus (00085412086309)

Device Identifier (DI) Information

Gelfoam Plus
1501341
Not in Commercial Distribution
1501341
BAXTER HEALTHCARE CORPORATION
00085412086309
GS1
October 20, 2021
1
628013963 *Terms of Use
GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
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Device Characteristics

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

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?
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.
Active true
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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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

530a8ae7-0cfd-4f4d-a261-22a2056c9094
July 27, 2023
5
December 21, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50085412086304 6 00085412086309 2021-10-20 Not in Commercial Distribution CASE
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Secondary DI

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

[?]
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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