DEVICE: PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint (00858439001330)

Device Identifier (DI) Information

PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint
9210584
In Commercial Distribution

HEMOSTASIS, LLC
00858439001330
GS1

1
801380697 *Terms of Use
PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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?
46922 Chitosan haemostatic agent, professional, non-bioabsorbable
A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.
Active false
64402 Intranasal splint, non-bioabsorbable, animal-derived
A non-bioabsorbable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made from animal-derived materials (e.g., chitosan) and is removed at the discretion of the physician. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EMX Balloon, Epistaxis
LYA Splint, Intranasal Septal
FRO Dressing, Wound, Drug
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120958 000
K122494 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Width: 1.5 Centimeter
Length: 5.1 Centimeter
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Device Record Status

595d2ad2-d60f-4ad6-b7c3-738ed27d235c
January 20, 2025
4
February 20, 2020
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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
00858439001354 3 00858439001330 In Commercial Distribution Carton
00858439001347 5 00858439001330 In Commercial Distribution Carton
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1 651-855-1466
customerservice@hemostasisllc.com
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