FDA.reportPublic FDA data

NEUWAVE

Primary DI
00818913020523
Brand
NEUWAVE
Company
NEUWAVE MEDICAL, INC.
Model
RCPK
Catalog number
RCPK
Device description
Surgical Clip, Dual, 15ga or 17ga Probe, 5 Pack
Published
2021-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEYSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200081000NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.2020-11-13NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818913020523PackageGS15In Commercial Distribution
00818913020516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818913020523008189130205238189130205230818913020523
00818913020516008189130205168189130205160818913020516

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system probe planar-coagulation guideA sterile surgical device designed to hold two or more microwave ablation probes together in a parallel configuration in order to facilitate planar coagulation of soft tissue prior to resection. It is a plastic device which fastens onto the hand-held probes to position them for the planar coagulation procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)323-9283info@neuwave.com

Regulatory Flags#

DUNS number
809758878
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818913020698NEUWAVEPRS35PRS352024-06-14
20818913020695NEUWAVEPRS35PRS352024-06-14
00818913020509NEUWAVEPRS15PRS152020-12-08
00853719006494NEUWAVERC17PKRC17PK2017-04-13
00853719006951NEUWAVENWA1US1NNWA1US1N2017-11-03
00853719006968NEUWAVENWC1US1RNWC1US1R2018-08-26
00818913020677NEUWAVEDR-001446CTBKT52021-10-14
00818913020196NEUWAVENWF1US1NNWF1US1N2017-09-22
00818913020257NEUWAVEAC-UPGRADEAC-UPGRADE2021-05-06
00853719006753NEUWAVENWC1US1NNWC1US1N2017-11-03
00818913020073NEUWAVENWF2HK1NNWF2HK1N2021-03-31
00818913020158NEUWAVENWF2SG1NNWF2SG1N2021-03-31
00818913020172NEUWAVENWF2CN1NNWF2CN1N2021-03-31
00818913020189NEUWAVEDR-000894DR-0008942021-03-31
00853719006005Certus® 1402.45 GHz Ablation SystemPR15cm - 17ga2016-09-18
00853719006012Certus® 1402.45 GHz Ablation SystemPR20cm - 17ga2016-09-18
00853719006029Certus® 1402.45 GHz Ablation SystemPR15cm - 15ga2016-09-18
00853719006036Certus® 1402.45 GHz Ablation SystemPR20cm - 15ga2016-09-18
00853719006043Certus® 1402.45 GHz Ablation SystemLK15cm - 17ga2016-09-18
00853719006050Certus® 1402.45 GHz Ablation SystemLK20cm - 17ga2016-09-18

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