Belotero Balance (+) Lidocaine

GUDID 07640123791343

Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels

ANTEIS SA

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID07640123791343
NIH Device Record Key038d3608-e2e4-4fbf-a18c-83b2d6afb447
Commercial Distribution StatusIn Commercial Distribution
Brand NameBelotero Balance (+) Lidocaine
Version Model Number8710M0S
Company DUNS482133837
Company NameANTEIS SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge
Total Volume1 Milliliter
Needle Gauge27 Gauge
Needle Gauge30 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze

Device Identifiers

Device Issuing AgencyDevice ID
GS107640123791343 [Primary]

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-09
Device Publish Date2023-06-01

On-Brand Devices [Belotero Balance (+) Lidocaine ]

07640123791220Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
07640123791138Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
07640123791343Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
07640123791145Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
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