DEVICE: Ultracell® (30886158012291)
Device Identifier (DI) Information
Ultracell®
NS10150-C
In Commercial Distribution
NS10150-C
Beaver-Visitec International, Inc.
NS10150-C
In Commercial Distribution
NS10150-C
Beaver-Visitec International, Inc.
***NON-STERILE*** EPISTAXIS PACK, 5.5 CM W/STRING (500/SP)
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EMX | BALLOON, EPISTAXIS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a dry place. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1f505a8c-ca8b-43f2-98ff-ed650427224e
July 05, 2024
1
June 27, 2024
July 05, 2024
1
June 27, 2024
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)906-8080
customersupport@bvimedical.com
customersupport@bvimedical.com