FDA.report

Phoenix Nickel Titanium

Primary DI
05060772895438
Brand
Phoenix Nickel Titanium
Company
PHOENIX ORTHODONTICS INC
Model
N-CCE10-9H
Catalog number
N-CCE10-9H
Device description
NT EVEN FORCE CLOSED COIL SPG W EYELET 9MM HEAVY .011X.042 PK10
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
ECOSPRING, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060772895421PrimaryGS10
05060772895438Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060772895421050607728954215060772895421
05060772895438050607728954385060772895438

GMDN Terms

TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. 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
10
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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