FDA.report

Jewel Precision

Primary DI
00850043393108
Brand
Jewel Precision
Company
Jewel Precision Sheet Metal & Machining Inc
Model
100-0003
Catalog number
100-0003
Device description
Filter, Single Use Only
Published
2023-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K162600000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850043393108PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
122140734
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850043393016Jewel PrecisionJP-24-62023-04-28
00850043393023Jewel PrecisionJP-24-CV100-00052023-04-28
00850043393092Jewel Precision100-0004100-00042023-04-28
00850043393115Jewel PrecisionSI-055ASI-055A2023-04-28
00850043393122Jewel PrecisionSI-055NSI-055N2023-04-28

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