FDA UDI In Commercial Distribution 🇺🇸 United States

PMT CORPORATION - STEREOTACTIC

DI: 00650551146452 · Model: 2103-190 · PMT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PMT CORPORATION - STEREOTACTIC
Primary DI
00650551146452
Version / Model
2103-190
Company Name
PMT CORPORATION
Labeler DUNS
039576871
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-07-12
Public Version
1
Public Version Date
2021-07-20
Public Version Status
New
Public Device Record Key
339922c6-1112-416f-9d04-5308d9b46984

Device Description

ALLEN WRENCH FOR MODEL 2103-188 AND 2103-189 DEPTH STOP

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
Yes
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 00650551146452

Premarket Submissions

Submission Number Supplement Number
K831329 000