FDA.reportPublic FDA data

ReNew

Primary DI
00811099010685
Brand
ReNew
Company
MICROLINE SURGICAL, INC.
Model
3708
Catalog number
3708
Device description
ReNew 18 Tip Sterilization Tray
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811099010685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811099010685008110990106858110990106850811099010685

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184080570
Device count
1
Lot or batch
true
Manufacturing date on label
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
00811099013822ReNew XR353035302023-06-07
00811099013839ReNew XR353135312023-06-07
00811099013846ReNew XR35322023-06-07
00811099013853ReNew XR35332023-06-07
00811099011408Microline102-137D102-137D2017-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006680Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006697Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006703Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006710Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006734Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006758Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006765Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006772Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006789Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006796Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006802Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006819Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006826Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006833Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006840Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006857Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006864Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006871Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006888Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006895Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006901Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006918Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00385640095297INSTRUSAFESummit Medical, Inc.KCT2026-10-22
00642356006215Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006222Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006239Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006246Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22