FDA.reportPublic FDA data

MIRABAY

Primary DI
05061075024365
Brand
MIRABAY
Company
Mirabay Orthodontics Corp.
Model
4UCO-MB
Catalog number
4UCO-MB
Device description
MIDNIGHT BLUE OPEN CHAIN 15FT SPOOL
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECIBand, elastic, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061075024365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061075024365050610750243655061075024365

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic inter-bracket elastic chainA non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949) 216-4758mirabayorthodontics@gmail.com

Regulatory Flags#

DUNS number
119374260
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05065025111884MIRABAY172-5003172-50032026-03-19
05065025111891MIRABAY172-5345172-53452026-03-19
05065025111907MIRABAY173-5345173-53452026-03-19
05065025111914MIRABAY174-5345174-53452026-03-19
05065025111921MIRABAY175-5345175-53452026-03-19
05065025111723MIRABAY051-7605051-76052026-03-17
05065025111730MIRABAY155-7605155-76052026-03-17
05065025111747MIRABAY156-7605156-76052026-03-17
05065025111754MIRABAY151-7605151-76052026-03-17
05065025111761MIRABAY152-7605152-76052026-03-17
05065025111778MIRABAY278-6301278-63012026-03-17
05065025111785MIRABAY278-6302278-63022026-03-17
05065025111792MIRABAY278-6303278-63032026-03-17
05065025111808MIRABAY278-6304278-63042026-03-17
05065025111815MIRABAY278-6101278-61012026-03-17
05065025111822MIRABAY278-6102278-61022026-03-17
05065025111839MIRABAY278-6103278-61032026-03-17
05065025111846MIRABAY278-6104278-61042026-03-17
05065025111853MIRABAY252-6401252-64012026-03-17
05065025111860MIRABAY252-7341252-73412026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205020JMUJMU DENTAL, INCECI2026-06-22
00840456205037JMUJMU DENTAL, INCECI2026-06-22
00840456205044JMUJMU DENTAL, INCECI2026-06-22
00840456205051JMUJMU DENTAL, INCECI2026-06-22
00840456205068JMUJMU DENTAL, INCECI2026-06-22
00840456205075JMUJMU DENTAL, INCECI2026-06-22
00840456205082JMUJMU DENTAL, INCECI2026-06-22
00840456205099JMUJMU DENTAL, INCECI2026-06-22
00840456205105JMUJMU DENTAL, INCECI2026-06-22
00840456205112JMUJMU DENTAL, INCECI2026-06-22
00840456205129JMUJMU DENTAL, INCECI2026-06-22
00840456205136JMUJMU DENTAL, INCECI2026-06-22
00840456205143JMUJMU DENTAL, INCECI2026-06-22
00840456205150JMUJMU DENTAL, INCECI2026-06-22
00840456205167JMUJMU DENTAL, INCECI2026-06-22
00840456205174JMUJMU DENTAL, INCECI2026-06-22
00840456205181JMUJMU DENTAL, INCECI2026-06-22
00840456205198JMUJMU DENTAL, INCECI2026-06-22
00840456205204JMUJMU DENTAL, INCECI2026-06-22
00840456205211JMUJMU DENTAL, INCECI2026-06-22
00840456205228JMUJMU DENTAL, INCECI2026-06-22
00840456205235JMUJMU DENTAL, INCECI2026-06-22
00840456205242JMUJMU DENTAL, INCECI2026-06-22
00840456205259JMUJMU DENTAL, INCECI2026-06-22
00840456205426JMUJMU DENTAL, INCECI2026-06-22
00840456205433JMUJMU DENTAL, INCECI2026-06-22
00840456205440JMUJMU DENTAL, INCECI2026-06-22
00840456205457JMUJMU DENTAL, INCECI2026-06-22
00840456205464JMUJMU DENTAL, INCECI2026-06-22
00840456205471JMUJMU DENTAL, INCECI2026-06-22