FDA.reportPublic FDA data

Phoenix Separators

Primary DI
05060772893601
Brand
Phoenix Separators
Company
PHOENIX ORTHODONTICS INC
Model
E-SWS
Catalog number
E-SWS
Device description
WHITE BULK RADIOPAQUE SEPARATORS SMALL PK1000
Published
2020-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
05060772893601PrimaryGS10
05060772893618Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060772893601050607728936015060772893601
05060772893618050607728936185060772893618

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic separatorA non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+18162286628kim@phoenixorthodontics.com

Regulatory Flags#

DUNS number
002092976
Device count
1000
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
05060772890365Phoenix Buccal TubeD-CS1B10-215ED-CS1B10-215E2020-08-17
05060772893748Phoenix Key TieE-T-KCORE-T-KCOR2020-08-17
05060779991225Phoenix Stainless SteelS-1B67-UR305S-1B67-UR3052020-08-17
05060779994363Phoenix Stainless SteelS-KT-012S-KT-0122020-08-17
05060779994462Phoenix Stainless SteelS-LT-011S-LT-0112020-08-17
05060779994486Phoenix Stainless SteelS-LT-012S-LT-0122020-08-17
05060772890044Phoenix OptimalD-80010-237BD-80010-237B2020-08-17
05060772890105Phoenix OptimalD-80010-238BD-80010-238B2020-08-17
05060772890129Phoenix OptimalD-80010-245BD-80010-245B2020-08-17
05060772890143Phoenix OptimalD-80010-246BD-80010-246B2020-08-17
05060772890167Phoenix Optimal 2XD-8012X10-235BD-8012X10-235B2020-08-17
05060772890181Phoenix Optimal 2XD-8012X10-236BD-8012X10-236B2020-08-17
05060772890204Phoenix Optimal 2XD-8012X10-255BD-8012X10-255B2020-08-17
05060772890228Phoenix Optimal 2XD-8012X10-256BD-8012X10-256B2020-08-17
05060772890242Phoenix Bondable ButtonD-BB-RCD-BB-RC2020-08-17
05060772890266Phoenix Bondable ButtonD-BBR-MFD-BBR-MF2020-08-17
05060772890280Phoenix Buccal TubeD-CS1B10-205ED-CS1B10-205E2020-08-17
05060772890303Phoenix Buccal TubeD-CS1B10-206ED-CS1B10-206E2020-08-17
05060772890327Phoenix Buccal TubeD-CS1B10-207ED-CS1B10-207E2020-08-17
05060772890341Phoenix Buccal TubeD-CS1B10-208ED-CS1B10-208E2020-08-17

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