FDA UDI In Commercial Distribution 🇺🇸 United States

PMT CORPORATION

DI: 00650551002703 · Model: 2103-220 · PMT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PMT CORPORATION
Primary DI
00650551002703
Version / Model
2103-220
Company Name
PMT CORPORATION
Labeler DUNS
039576871
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-10-25
Public Version
1
Public Version Date
2021-11-02
Public Version Status
New
Public Device Record Key
fa136be2-a6dc-496c-9f66-a024aa9875d8

Device Description

2.1MM SPLIT BUSHING FOR ROSA SEEG DEPTH PLACEMENT

Device Characteristics

Single Use
Yes
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
No
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
Yes
Sterilization Methods
Hydrogen Peroxide

Product Codes

Code Name
HAW Neurological Stereotaxic Instrument

GMDN Terms

Code Name
32568 Neurological stereotactic surgery system

Identifiers

Type ID
Primary 00650551002703

Premarket Submissions

Submission Number Supplement Number
K831329 000