FDA.reportPublic FDA data

Orthopli

Primary DI
D917OP100
Brand
Orthopli
Company
ORTHOPLI CORP.
Model
OP10
Published
2019-08-06
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
D917OP100PrimaryHIBCC0

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
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam 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
D917OP110OrthopliOP112019-08-06
D917OP120OrthopliOP122019-08-06
D917OP130OrthopliOP132019-08-06
D917OP140OrthopliOP142019-08-06
D917OP20OrthopliOP22019-08-02
D917OP30OrthopliOP32019-08-06
D917OP40OrthopliOP42019-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437695MilleniumAvalign Technologies, Inc.KCT2026-10-20
00385640095174INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095181INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095198INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095204INSTRUSAFESummit Medical, Inc.KCT2026-10-20
G476STER16X5X1625SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-20
00385640095167INSTRUSAFESummit Medical, Inc.KCT2026-10-16
10886982312327NASynthes GmbHKCT2026-10-16
10886982346704VOLTSynthes GmbHKCT2026-10-16
10886982346735VOLTSynthes GmbHKCT2026-10-16
10886982363282NASynthes GmbHKCT2026-10-16
10886982363299NASynthes GmbHKCT2026-10-16
10886982363305NASynthes GmbHKCT2026-10-16
10886982363312NASynthes GmbHKCT2026-10-16
00385640095082INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095099INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095105INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095112INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095129INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095136INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095143INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095150INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00724995239909V. MuellerSteris CorporationKCT2026-10-15
00724995239916V. MuellerSteris CorporationKCT2026-10-15
00724995239923V. MuellerSteris CorporationKCT2026-10-15
00724995239930V. MuellerSteris CorporationKCT2026-10-15
00724995239947V. MuellerSteris CorporationKCT2026-10-15
00724995240660V. MuellerSteris CorporationKCT2026-10-15
00724995240677V. MuellerSteris CorporationKCT2026-10-15
00724995240684V. MuellerSteris CorporationKCT2026-10-15