FDA UDI In Commercial Distribution 🇺🇸 United States

Biometrics Ltd M550 MyoMeter

DI: 05060481690096 · Model: M550 · BIOMETRICS LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Biometrics Ltd M550 MyoMeter
Primary DI
05060481690096
Version / Model
M550
Company Name
BIOMETRICS LIMITED
Labeler DUNS
519969810
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-10
Public Version
3
Public Version Date
2018-08-10
Public Version Status
Update
Public Device Record Key
d3b8e62c-bd22-4ee8-b2f3-f24711cd0288

Device Description

The MyoMeter allows the user to quantify the force applied during Manual Muscle Testing.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IKK System, Isokinetic Testing And Evaluation
ISD Exerciser, Measuring

GMDN Terms

Code Name
61672 Back/leg/chest dynamometer, electronic

Identifiers

Type ID
Primary 05060481690096