FDA.report

Pro Advantage

Primary DI
M220P2121005
Brand
Pro Advantage
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
P212100
Catalog number
P212100
Device description
Pro Advantage Cautery Fine Tip Hi Temp
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HQPUnit, Cautery, Thermal, Battery-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HQPUnit, Cautery, Thermal, Battery-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M220P2121005PrimaryHIBCC0

GMDN Terms

TermDefinition
Electrocautery system generator, battery-poweredA battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.

Sterilization Methods

Method

Contacts

PhoneEmail
6153663230compliance@ndc-inc.com

Regulatory Flags

DUNS number
009831413
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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