FDA.reportPublic FDA data

Electro Lavage

Primary DI
00817984010419
Brand
Electro Lavage
Company
MECTRA LABS, INC.
Model
0600-3101-000
Catalog number
0600-3101-000
Device description
Electro Lavage Spatula Single Spike
Published
2019-01-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817984010416PackageGS110Not in Commercial Distribution
00817984010419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081798401041610817984010416
00817984010419008179840104198179840104190817984010419

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Fahrenheit115 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-3968mectrasales@mectralabs.com

Regulatory Flags#

DUNS number
606939072
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817984011195Richard Wolf0600-2160-0000600-2160-0002019-01-29
00817984010211Electro Lube0600-EL101-0000600-EL101-0002019-01-24
00817984010228Electro Lube0600-EL102-0000600-EL102-0002019-01-28
00817984010402Electro Lavage0600-3100-0000600-3100-0002019-01-25
00817984010426Electro Lavage0600-3102-0000600-3102-0002019-01-25
00817984010433Electro Lavage0600-3103-0000600-3103-0002019-01-25
00817984010440Electro Lavage0600-3110-0000600-3110-0002019-01-25
00817984010457Electro Lavage0600-3111-0000600-3111-0002019-01-25
00817984010464Electro Lavage0600-3112-0000600-3112-0002019-01-24
00817984010471Electro Lavage0600-3113-0000600-3113-0002019-01-25
00817984010488Electro Lavage0600-3120-0000600-3120-0002019-01-25
00817984010495Electro Lavage0600-3121-0000600-3121-0002019-01-25
00817984010501Electro Lavage0600-3122-0000600-3122-0002019-01-29
00817984010518Electro Lavage0600-3123-0000600-3123-0002019-01-25
00817984010525Electro Lavage0600-3130-0000600-3130-0002019-01-25
00817984010532Electro Lavage0600-3131-0000600-3131-0002019-01-29
00817984010549Electro Lavage0600-3132-0000600-3132-0002019-01-25
00817984010556Electro Lavage0600-3133-0000600-3133-0002019-01-25
00817984010563Electro Lavage0600-3140-0000600-3140-0002019-01-24
00817984010570Electro Lavage0600-3141-0000600-3141-0002019-01-25

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Primary DI, Brand, Company table
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