FDA UDI In Commercial Distribution 🇺🇸 United States

JMU

DI: D910216010020 · Model: 21601002 · JMU DENTAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
JMU
Primary DI
D910216010020
Version / Model
21601002
Company Name
JMU DENTAL, INC
Labeler DUNS
081258380
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-05-14
Public Version
1
Public Version Date
2024-05-22
Public Version Status
New
Public Device Record Key
a9e52933-887a-4fbf-9716-2f43abdc07b1

Device Description

JMU Gutta Percha Obturator, Soft Type, 100pcs/Bottle

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
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EKM Gutta-Percha

GMDN Terms

Code Name
31872 Natural gutta-percha

Identifiers

Type ID
Primary D910216010020