FDA UDI In Commercial Distribution 🇺🇸 United States

TEMREX BITE WING TABS

DI: 00850015110511 · Model: 015, 2450 · TEMREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
TEMREX BITE WING TABS
Primary DI
00850015110511
Version / Model
015, 2450
Company Name
TEMREX CORPORATION
Labeler DUNS
012072823
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-03-09
Public Version
1
Public Version Date
2022-03-17
Public Version Status
New
Public Device Record Key
b1ec8e2a-127d-4c21-89df-1dc73f0e0cfb

Device Description

DENTAL X-RAY FILM HOLDER

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EGZ Holder, Film, X-Ray

GMDN Terms

Code Name
16205 Dental x-ray film holder, reusable

Identifiers

Type ID
Primary 00850015110511