Ortho Pro

GUDID 00810152826256

lingual sheath Weldable Without Hook with indent 10 pcs/pk

Ortho Pro Dent LLC

Orthodontic metal band

Primary Device ID	00810152826256
NIH Device Record Key	7620a30c-12de-418e-bf6a-1c738742e951
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ortho Pro
Version Model Number	CSS-LS-101
Company DUNS	085719913
Company Name	Ortho Pro Dent LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com
Phone	941-402-6504
Email	edward@orthoprodent.com

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810152826256 [Primary]

FDA Product Code

ECM	Band, Preformed, Orthodontic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-11-13
Device Publish Date	2024-11-05

On-Brand Devices [Ortho Pro]

00810152826300	lingual sheath Bondable Without Hook or Indent 10 pcs/pk
00810152826294	lingual sheath Weldable With hook / with indent( mesial R) 10 pcs/pk
00810152826287	lingual sheath Weldable With hook / with indent (mesial L) 10 pcs/pk
00810152826270	lingual sheath Weldable With hook /with indent (distal R) 10 pcs/pk
00810152826263	lingual sheath Weldable With Hook /with indent( distal L) 10 pcs/pk
00810152826256	lingual sheath Weldable Without Hook with indent 10 pcs/pk
00810152826249	lingual sheath Weldable Without Hook or Indent 10 pcs/pk
00810152826232	Lingual Cleats Long 10 pcs/pk
00810152826225	Lingual Cleats Short 10 pcs/pk
00810152826140	Crimpable Stops Crimpable Stops Universal 10 pcs/pk
00810152826133	Crimpable Spiral Hooks Universal Right 10 mm 10 pcs/pk
00810152826126	Crimpable Spiral Hooks Universal Left 10 mm 10 pcs/pk
00810152826119	Crimpable Spiral Hooks Universal Right 8.5 mm 10 pcs/pk
00810152826102	Crimpable Spiral Hooks Universal Left 8.5 mm 10 pcs/pk
00810152826096	Crimpable Archwire Hooks Universal Right 7.0 mm 10 pcs/pk
00810152826089	Crimpable Archwire Hooks Universal Left 7.0 mm 10 pcs/pk
00810152826072	Crimpable Hooks Ball-Top Universal 7.0 mm 10 pcs/pk
00810152826065	Crimpable Hooks Ball-Top Universal 5.5 mm 10 pcs/pk
00810152826058	Crimpable Hooks Ball-Top Universal 4.0 mm 10 pcs/pk
00810152826041	Crimpable Hooks Ball-Top Universal 2.7 mm 10 pcs/pk
00810152826034	Crimpable Hooks Ball-Top Universal 2.1 mm 10 pcs/pk
00810152826027	Crimpable Hooks T-Top Universal 7.0 mm 10 pcs/pk
00810152826010	Crimpable Hooks T-Top Universal 5.5 mm 10 pcs/pk
00810152826003	Crimpable Hooks T-Top Universal 4.0 mm 10 pcs/pk
00810152825990	Crimpable Hooks T-Top Universal 2.7 mm 10 pcs/pk
00810152825983	Crimpable Hooks T-Top Universal 2.1 mm 10 pcs/pk
00810152825976	Patient Relief Wax Assorted 50pcs/pk
00810152825969	Patient Relief Wax Osmanthus 50pcs/pk
00810152825952	Patient Relief Wax Grape 50pcs/pk
00810152825945	Patient Relief Wax Pineapple 50pcs/pk
00810152825938	Patient Relief Wax Strawberry 50pcs/pk
00810152825921	Patient Relief Wax Orange 50pcs/pk
00810152825914	Patient Relief Wax Apple 50pcs/pk
00810152825907	Patient Relief Wax Rose 50pcs/pk
00810152825891	Patient Relief Wax Lemon 50pcs/pk
00810152825884	Patient Relief Wax Unscented 50pcs/pk
00810152826829	Lip Bumpers White With Hook
00810152826812	Lip Bumpers Blue With Hook
00810152826805	Lip Bumpers Pink With Hook
00810152826799	Lip Bumpers Red With Hook
00810152826782	Lip Bumpers Yellow With Hook
00810152826775	Lip Bumpers White Without Hook
00810152826768	Lip Bumpers Blue Without Hook
00810152826751	Lip Bumpers Pink Without Hook
00810152826744	Lip Bumpers Red Without Hook
00810152826737	Lip Bumpers Yellow Without Hook
00810152826720	High Pull Head Caps
00810152826713	Safety Release Modules
00810152826706	Neck pads with Straps
00810152826690	Facebows size #5 ,lingual arch 115 mm, length 111 mm medium