DEVICE: BELLAFILL (00350224000028)

Device Identifier (DI) Information

BELLAFILL
1.0 cc
In Commercial Distribution
GBF0208, GBF0508
SUNEVA MEDICAL, INC.
00350224000028
GS1

1
012844615 *Terms of Use
Bellafill 1.0cc syringe
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
LMH Implant, Dermal, For Aesthetic Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P020012 008
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: DO NOT FREEZE
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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

a1f7297f-4d4b-48de-92c6-3d05fd8391fc
July 06, 2018
4
December 01, 2014
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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
10350224000025 5 00350224000028 In Commercial Distribution 5 syringes per box
20350224000022 2 00350224000028 In Commercial Distribution 2 syringes per box
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
858-550-9999
customersupport@sunevamedical.com
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