FDA.reportPublic FDA data

ReNew XR

Primary DI
00811099013822
Brand
ReNew XR
Company
MICROLINE SURGICAL, INC.
Model
3530
Catalog number
3530
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K201884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201884000ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cmMicroline Surgical, Inc.2020-10-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811099013822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811099013822008110990138228110990138220811099013822

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn 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 is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184080570
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811099014386REVEEL - Endoscopic Retractor - PercutaneousRV0930012025-09-22
00811099014416REVEEL - Endoscopic Retractor - TrocarRT0830012025-09-22
00811099014393REVEEL - Endoscopic Retractor - PercutaneousRV0930012025-09-22
00811099014423REVEEL - Endoscopic Retractor - TrocarRT0830012025-09-22
00811099014348ReNew Disposable Tenaculum Tip (5mm)33922025-09-09
00811099014362ReNew Disposable Tenaculum Tip (10mm)34222025-09-09
00811099014331ReNew Disposable Tenaculum Tip (5mm)33922025-09-09
00811099014355ReNew Disposable Tenaculum Tip (10mm)34222025-09-09
00811099014294ReNew XR Handpiece with Reference Length Markings3944M2024-05-03
00081109901429ReNew XR Handpiece with Reference Length Markings3944M2024-05-03
00811099014256ReNew XR Handpiece with Reference Length Markings3943M2024-05-03
00811099014263ReNew XR Handpiece with Reference Length Markings3941M2024-05-03
00811099014270ReNew XR Handpiece with Reference Length Markings3942M2024-05-03
00811099014287ReNew XR Handpiece with Reference Length Markings3946M2024-05-03
00811099014300ReNew XR Handpiece with Reference Length Markings3945M2024-05-03
00811099013839ReNew XR353135312023-06-07
00811099013846ReNew XR35322023-06-07
00811099013853ReNew XR35332023-06-07
00811099011408Microline102-137D102-137D2017-11-13
00811099011415Microline102-138D102-138D2017-11-13

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Primary DI, Brand, Company table
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