DEVICE: BELLAFILL (00350224000028)
Device Identifier (DI) Information
BELLAFILL
1.0 cc
In Commercial Distribution
GBF0208, GBF0508
SUNEVA MEDICAL, INC.
1.0 cc
In Commercial Distribution
GBF0208, GBF0508
SUNEVA MEDICAL, INC.
Bellafill 0.8ml on 1.0cc syringe
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
59130 | Dermal tissue reconstructive material, animal-derived |
A sterile, bioabsorbable, animal-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), to correct cutaneous contour deformities (e.g., scars) associated with aging, injury, or degenerative lesions; it may in addition be used as a bulking material for incontinence treatment (e.g., in the urinary tract). It does not include a local anaesthetic agent. It includes animal-derived collagen or hyaluronic acid (HA) [e.g., porcine, bovine]. It is typically preloaded in a disposable syringe.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LMH | Implant, Dermal, For Aesthetic Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P020012 | 008 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: DO NOT FREEZE |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a1f7297f-4d4b-48de-92c6-3d05fd8391fc
September 14, 2022
6
December 01, 2014
September 14, 2022
6
December 01, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10350224000025 | 5 | 00350224000028 | In Commercial Distribution | 5 syringes per box | |
20350224000022 | 2 | 00350224000028 | In Commercial Distribution | 2 syringes per box |
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
[?]
858-550-9999
customersupport@sunevamedical.com
customersupport@sunevamedical.com