DEVICE: Bio-XC™ Foam (10841307123699)
Device Identifier (DI) Information
Bio-XC™ Foam
BIO-XCF
In Commercial Distribution
BIO-XCF
IMPLANT DIRECT SYBRON MANUFACTURING LLC
BIO-XCF
In Commercial Distribution
BIO-XCF
IMPLANT DIRECT SYBRON MANUFACTURING LLC
"Bio-XC™ Foam Resorbable Collagen - 20mm x 40mm, 3 mm Thickness"
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
47184 | General oral wound dressing, animal-derived |
A collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KGN | Dressing, Wound, Collagen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Width: 20mm Length: 40mm Thickness: 3mm |
Device Record Status
e5cc164e-7246-4416-8a83-d41f103682c2
July 07, 2020
2
September 26, 2019
July 07, 2020
2
September 26, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20841307123696 | 10 | 10841307123699 | In Commercial Distribution | Chipboard Carton |
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
[?]
1-888-649-6425
customerservice@implantdirect.com
customerservice@implantdirect.com