FDA UDI In Commercial Distribution 🇺🇸 United States

Universal

DI: D003B10730561 · Model: B1073056 · Dentsply International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

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Basic Information

Brand Name
Universal
Primary DI
D003B10730561
Version / Model
B1073056
Catalog Number
B1073056
Company Name
Dentsply International Inc.
Labeler DUNS
795572718
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2024-11-06
Public Version
1
Public Version Date
2024-11-14
Public Version Status
New
Public Device Record Key
6e630cd6-2177-462e-a4d6-de90dd7a2cfe

Device Description

UNIVRSL ENDODONTIC HLDRR ASSY KIT

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
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
EGZ Holder, film, x-ray

GMDN Terms

Code Name
16205 Dental x-ray film holder, reusable

Identifiers

Type ID
Unit of Use D003B10730560
Primary D003B10730561