BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

SWISS DOLORCLAST

DI: 07613353226053 · Model: A · E.M.S. Electro Medical Systems S.A.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: SWISS DOLORCLAST
Primary DI: 07613353226053
Version / Model: A
Catalog Number: FT-250#A/002
Company Name: E.M.S. Electro Medical Systems S.A.
Labeler DUNS: 481233849
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-09-13
Public Version: 1
Public Version Date: 2022-09-21
Public Version Status: New
Public Device Record Key: 02bc0a5f-957f-4992-b6c5-4ca9c0e61455

Device Description

DolorClast Radial

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

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47032	Pneumatic orthopaedic extracorporeal shock wave therapy system	An assembly of devices designed to provide pneumatic orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a control unit that produces pneumatically-generated shock waves at selected impulse frequencies, and a hand-held surface applicator used to apply the energy to the site of pain. It is commonly used to treat disorders such as tendinopathies (e.g., rotator cuff, patellar, Achilles), soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), shin splints, and muscle-related pain syndromes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613353226053	GS1

Customer Contacts

Phone: +41229944700
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K220538	000

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 10 – 85 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -10 – 30 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 35 – 65 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 10 – 30 Degrees Celsius
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal