FDA.reportPublic FDA data

Electro Lavage

Primary DI
10817984010584
Brand
Electro Lavage
Company
MECTRA LABS, INC.
Model
0600-3142-000
Catalog number
0600-3142-000
Device description
Electro Lavage Needle Dual 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
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955352000SUCTION CAUTERY PROBEMectra Labs, Inc.1996-04-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817984010584PackageGS110Not in Commercial Distribution
00817984010587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081798401058410817984010584
00817984010587008179840105878179840105870817984010587

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical 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 may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
606939072
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
true
Sterilization required before use
false

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
00817984010419Electro Lavage0600-3101-0000600-3101-0002019-01-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13