FDA UDI In Commercial Distribution 🇺🇸 United States

EMG Shorting Leads, Shielded

DI: 00627825014601 · Model: CAB150 · Laborie Medical Technologies Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EMG Shorting Leads, Shielded
Primary DI
00627825014601
Version / Model
CAB150
Company Name
Laborie Medical Technologies Corp.
Labeler DUNS
117783313
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-10
Public Version
2
Public Version Date
2023-12-18
Public Version Status
Update
Public Device Record Key
c8e76e56-18e0-4620-8c48-5b1ce6354f6e

Device Description

EMG Shorting Leads, Shielded

Device Characteristics

Single Use
No
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
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
FEN Device, Cystometric, Hydraulic

GMDN Terms

Code Name
35750 Analytical non-scalp cutaneous lead

Identifiers

Type ID
Primary 00627825014601

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
-29 – 60 Degrees Celsius
Type
Handling Environment Humidity
Temperature Range
15 – 85 Percent (%) Relative Humidity