FDA.report

Ormco Premium

Primary DI
00889989082425
Brand
Ormco Premium
Company
ORMCO CORPORATION
Model
866-2030
Device description
OMEGA LOOP FORMING PLIERS
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JEXPLIER, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889989082425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989082425008899890824258899890824250889989082425

GMDN Terms

TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags

DUNS number
154614119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10889989012269Straight-Wire Synthesis338-03112024-03-07
10889989012276Straight-Wire Synthesis338-04102024-03-07

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