AccessGUDID - DEVICE: Belotero Balance (07640123791213)

GUDID

Device Identifier (DI) Information

Brand Name: Belotero Balance
Version or Model: 8700M0S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANTEIS SA

Primary DI Number: 07640123791213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482133837 *Terms of Use

Device Description: Belotero Balance 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 gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59131	Dermal tissue reconstructive material, microbe-derived	A sterile, bioabsorbable, bacteria-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), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it does not include a local anaesthetic agent. It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.	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 [?]
P090016	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: DO NOT FREEZE
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 27 Gauge
Needle Gauge: 30 Gauge
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: 05061181-8070-45c6-bf0e-58480954e17f
Public Version Date: October 09, 2020
Public Version Number: 1
DI Record Publish Date: October 01, 2020