FDA.reportPublic FDA data

Jewel Precision

Primary DI
00850043393023
Brand
Jewel Precision
Company
Jewel Precision Sheet Metal & Machining Inc
Model
JP-24-CV
Catalog number
100-0005
Device description
JP-24-CV Cover gasket, replacement part
Published
2023-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162600000Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc.2016-12-09KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043393023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043393023008500433930238500433930230850043393023

GMDN Terms#

Term, Definition table
TermDefinition
Instrument transport trolley systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
122140734
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043393016Jewel PrecisionJP-24-62023-04-28
00850043393092Jewel Precision100-0004100-00042023-04-28
00850043393108Jewel Precision100-0003100-00032023-04-28
00850043393115Jewel PrecisionSI-055ASI-055A2023-04-28
00850043393122Jewel PrecisionSI-055NSI-055N2023-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094016INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640094023INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640093972INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640093989INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640094009INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00724995239879V. MuellerSteris CorporationKCT2026-08-18
00724995239886V. MuellerSteris CorporationKCT2026-08-18
00724995239893V. MuellerSteris CorporationKCT2026-08-18
00724995240615V. MuellerSteris CorporationKCT2026-08-18
00724995240622V. MuellerSteris CorporationKCT2026-08-18
00724995240639V. MuellerSteris CorporationKCT2026-08-18
00724995240714V. MuellerSteris CorporationKCT2026-08-18
00724995240721V. MuellerSteris CorporationKCT2026-08-18
00724995240738V. MuellerSteris CorporationKCT2026-08-18
00724995240745V. MuellerSteris CorporationKCT2026-08-18
00724995240752V. MuellerSteris CorporationKCT2026-08-18
00724995240769V. MuellerSteris CorporationKCT2026-08-18
00724995240776V. MuellerSteris CorporationKCT2026-08-18
00724995240783V. MuellerSteris CorporationKCT2026-08-18
00724995240790V. MuellerSteris CorporationKCT2026-08-18
00724995240806V. MuellerSteris CorporationKCT2026-08-18
00724995240813V. MuellerSteris CorporationKCT2026-08-18
00724995240820V. MuellerSteris CorporationKCT2026-08-18
00724995240837V. MuellerSteris CorporationKCT2026-08-18
00724995240844V. MuellerSteris CorporationKCT2026-08-18
00724995240851V. MuellerSteris CorporationKCT2026-08-18
00724995240868V. MuellerSteris CorporationKCT2026-08-18
00724995240875V. MuellerSteris CorporationKCT2026-08-18
00724995240882V. MuellerSteris CorporationKCT2026-08-18
00724995240899V. MuellerSteris CorporationKCT2026-08-18