FDA.reportPublic FDA data

Orthopli

Primary DI
D917OP20
Brand
Orthopli
Company
ORTHOPLI CORP.
Model
OP2
Published
2019-08-02
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
K101653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101653000MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESMiltex, Inc.2010-08-02KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D917OP20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, reusableA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Regulatory Flags#

DUNS number
071465330
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D917OO9W0OrthopliOO9-W009W2019-10-01
D917O11C0OrthopliO11-CO11-C2020-09-04
D917O120OrthopliO12O122020-09-04
D917O12CB0OrthopliO12-CBO12-CB2020-09-04
D917O12CD0OrthopliO12-CDO12-CD2020-09-04
D917O12P0Orthopli O12-PO12-P2020-09-02
D917O12PB0OrthopliO12-PBO12-PB2020-09-02
D917O12PD0OrthopliO12-PDO12-PD2020-09-02
D917O12PM0OrthopliO12-PMO12-PM2020-09-02
D917O12PS0OrthopliO12-PSO12-PS2020-09-02
D917O16SH0OrthopliO16-SHO16-SH2020-09-01
D917O18A0OrthopliO18-AO18-A2020-09-01
D917O16P0OrthopliO16-PO16-P2020-08-28
D917OP100OrthopliOP102019-08-06
D917OP110OrthopliOP112019-08-06
D917OP120OrthopliOP122019-08-06
D917OP130OrthopliOP132019-08-06
D917OP140OrthopliOP142019-08-06
D917OP30OrthopliOP32019-08-06
D917OP40OrthopliOP42019-08-06

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Primary DI, Brand, Company table
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07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
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07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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