FDA UDI In Commercial Distribution 🇺🇸 United States

Intraoral Cheek Retractors

DI: 00190730032928 · Model: 601-211 · ORTHO TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Intraoral Cheek Retractors
Primary DI
00190730032928
Version / Model
601-211
Company Name
ORTHO TECHNOLOGY, INC.
Labeler DUNS
781772017
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-15
Public Version
1
Public Version Date
2019-05-23
Public Version Status
New
Public Device Record Key
095620b3-67a0-4d6f-9d3b-35f8ee91eb1d

Device Description

Retractor Intraoral Aclv Med Autoclavable up to 270°

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EIF ACCESSORIES, RETRACTOR, DENTAL

GMDN Terms

Code Name
44828 Dental cheek retractor, professional, reusable

Identifiers

Type ID
Primary 00190730032928