FDA.report

Phoenix Stainless Steel

Primary DI
05060779995322
Brand
Phoenix Stainless Steel
Company
PHOENIX ORTHODONTICS INC
Model
S-WB-CS1814
Catalog number
S-WB-CS1814
Device description
.018 MBT WELD SS BT UP LEFT SGL CONVERT -14T:10DO PK5
Published
2020-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060779995315PrimaryGS10
05060779995322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060779995315050607799953155060779995315
05060779995322050607799953225060779995322

GMDN Terms

TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800) 642-3009sales@phoenixorthodontics.com
+18162286594sales@phoenixorthodontics.com
+18162286628kim@phoenixorthodontics.com

Regulatory Flags

DUNS number
002092976
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05060772890051Phoenix Elastic AttachersAX-ELA-MIXAX-ELA-MIX2020-08-17
05060772890068OrthoGap Archwire MarkersAX-WOMOGAX-WOMOG2020-08-17
05060772890075Phoenix Composite ButtonsC-CB-1021-BC-CB-1021-B2020-08-17
05060772890082Phoenix Composite ButtonsC-CB-504-BC-CB-504-B2020-08-17
05060772890099Phoenix OptimalD-80010-237BD-80010-237B2020-08-17
05060772890112Phoenix OptimalD-80010-238BD-80010-238B2020-08-17
05060772890136Phoenix OptimalD-80010-245BD-80010-245B2020-08-17
05060772890150Phoenix OptimalD-80010-246BD-80010-246B2020-08-17
05060772890174Phoenix Optimal 2XD-8012X10-235BD-8012X10-235B2020-08-17
05060772890198Phoenix Optimal 2XD-8012X10-236BD-8012X10-236B2020-08-17
05060772890211Phoenix Optimal 2XD-8012X10-255BD-8012X10-255B2020-08-17
05060772890235Phoenix Optimal 2XD-8012X10-256BD-8012X10-256B2020-08-17
05060772890259Phoenix Bondable ButtonD-BB-RCD-BB-RC2020-08-17
05060772890273Phoenix Bondable ButtonD-BBR-MFD-BBR-MF2020-08-17
05060772890297Phoenix Buccal TubeD-CS1B10-205ED-CS1B10-205E2020-08-17
05060772890310Phoenix Buccal TubeD-CS1B10-206ED-CS1B10-206E2020-08-17
05060772890334Phoenix Buccal TubeD-CS1B10-207ED-CS1B10-207E2020-08-17
05060772890358Phoenix Buccal TubeD-CS1B10-208ED-CS1B10-208E2020-08-17
05060772890372Phoenix Buccal TubeD-CS1B10-215ED-CS1B10-215E2020-08-17
05060772890396Phoenix Buccal TubeD-CS1B10-216ED-CS1B10-216E2020-08-17

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