Ortho Pro

GUDID 00810152826256

lingual sheath Weldable Without Hook with indent 10 pcs/pk

Ortho Pro Dent LLC

Orthodontic metal band
Primary Device ID00810152826256
NIH Device Record Key7620a30c-12de-418e-bf6a-1c738742e951
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrtho Pro
Version Model NumberCSS-LS-101
Company DUNS085719913
Company NameOrtho Pro Dent LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810152826256 [Primary]

FDA Product Code

ECMBand, Preformed, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-13
Device Publish Date2024-11-05

On-Brand Devices [Ortho Pro]

00810152826300lingual sheath Bondable Without Hook or Indent 10 pcs/pk
00810152826294lingual sheath Weldable With hook / with indent( mesial R) 10 pcs/pk
00810152826287lingual sheath Weldable With hook / with indent (mesial L) 10 pcs/pk
00810152826270lingual sheath Weldable With hook /with indent (distal R) 10 pcs/pk
00810152826263lingual sheath Weldable With Hook /with indent( distal L) 10 pcs/pk
00810152826256lingual sheath Weldable Without Hook with indent 10 pcs/pk
00810152826249lingual sheath Weldable Without Hook or Indent 10 pcs/pk
00810152826232Lingual Cleats Long 10 pcs/pk
00810152826225Lingual Cleats Short 10 pcs/pk
00810152826140Crimpable Stops Crimpable Stops Universal 10 pcs/pk
00810152826133Crimpable Spiral Hooks Universal Right 10 mm 10 pcs/pk
00810152826126Crimpable Spiral Hooks Universal Left 10 mm 10 pcs/pk
00810152826119Crimpable Spiral Hooks Universal Right 8.5 mm 10 pcs/pk
00810152826102Crimpable Spiral Hooks Universal Left 8.5 mm 10 pcs/pk
00810152826096Crimpable Archwire Hooks Universal Right 7.0 mm 10 pcs/pk
00810152826089Crimpable Archwire Hooks Universal Left 7.0 mm 10 pcs/pk
00810152826072Crimpable Hooks Ball-Top Universal 7.0 mm 10 pcs/pk
00810152826065Crimpable Hooks Ball-Top Universal 5.5 mm 10 pcs/pk
00810152826058Crimpable Hooks Ball-Top Universal 4.0 mm 10 pcs/pk
00810152826041Crimpable Hooks Ball-Top Universal 2.7 mm 10 pcs/pk
00810152826034Crimpable Hooks Ball-Top Universal 2.1 mm 10 pcs/pk
00810152826027Crimpable Hooks T-Top Universal 7.0 mm 10 pcs/pk
00810152826010Crimpable Hooks T-Top Universal 5.5 mm 10 pcs/pk
00810152826003Crimpable Hooks T-Top Universal 4.0 mm 10 pcs/pk
00810152825990Crimpable Hooks T-Top Universal 2.7 mm 10 pcs/pk
00810152825983Crimpable Hooks T-Top Universal 2.1 mm 10 pcs/pk
00810152825976Patient Relief Wax Assorted 50pcs/pk
00810152825969Patient Relief Wax Osmanthus 50pcs/pk
00810152825952Patient Relief Wax Grape 50pcs/pk
00810152825945Patient Relief Wax Pineapple 50pcs/pk
00810152825938Patient Relief Wax Strawberry 50pcs/pk
00810152825921Patient Relief Wax Orange 50pcs/pk
00810152825914Patient Relief Wax Apple 50pcs/pk
00810152825907Patient Relief Wax Rose 50pcs/pk
00810152825891Patient Relief Wax Lemon 50pcs/pk
00810152825884Patient Relief Wax Unscented 50pcs/pk

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