FDA UDI In Commercial Distribution 🇺🇸 United States

Maquira

DI: 07898938244480 · Model: CONE POSITIONER AUTOCLAVABLE CHILDREN · Maquira Industria de Produtos Odontologicos S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Maquira
Primary DI
07898938244480
Version / Model
CONE POSITIONER AUTOCLAVABLE CHILDREN
Catalog Number
80322400059
Company Name
Maquira Industria de Produtos Odontologicos S/A
Labeler DUNS
679266866
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-08-07
Public Version
1
Public Version Date
2024-08-15
Public Version Status
New
Public Device Record Key
5a7cdcac-ae64-4912-bf00-ca1c60563416

Device Description

The AUTOCLAVABLE CONE POSITIONER helps guide the angle of the dental x-ray machine in periodontal procedures, resulting in standardized, clear radiographic images.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
EGZ Holder, Film, X-Ray

GMDN Terms

Code Name
61131 Radiological general body-part positioner

Identifiers

Type ID
Primary 07898938244480