FDA UDI In Commercial Distribution 🇺🇸 United States

Pomee

DI: G157701200 · Model: 701-200 · POMEE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Pomee
Primary DI
G157701200
Version / Model
701-200
Catalog Number
701-200
Company Name
POMEE CORPORATION
Labeler DUNS
645717646
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-12-24
Public Version
1
Public Version Date
2022-01-03
Public Version Status
New
Public Device Record Key
c921c7f0-25f8-4776-9b6f-608cd61423dc

Device Description

Amalgam Condensers And Pluggers Back Action # 9/10

Device Characteristics

Single Use
No
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
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Dry Heat Sterilization, Moist Heat or Steam Sterilization

Product Codes

Code Name
EKG Condenser, Amalgam And Foil, Operative

GMDN Terms

Code Name
16460 Dental amalgam condenser, reusable

Identifiers

Type ID
Primary G157701200