DEVICE: Ultracell® (30886158012291)

Device Identifier (DI) Information

Ultracell®
NS10150-C
In Commercial Distribution
NS10150-C
Beaver-Visitec International, Inc.
30886158012291
GS1

1
001406024 *Terms of Use
***NON-STERILE*** EPISTAXIS PACK, 5.5 CM W/STRING (500/SP)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
46941 ENT space-occupying dressing, human-derived
A sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery. It is typically available as gel or gelatin sponge of human tissue origin. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
EMX BALLOON, EPISTAXIS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry place.
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Clinically Relevant Size

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

1f505a8c-ca8b-43f2-98ff-ed650427224e
July 05, 2024
1
June 27, 2024
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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
No Package DIs found
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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+1(866)906-8080
customersupport@bvimedical.com
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