FDA.reportPublic FDA data

SkyOPS

Primary DI
00850024702561
Brand
SkyOPS
Company
Sky Surgical, LLC
Model
S0021
Device description
SkyOPS Sterilization Tray Lid
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233154000SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC2023-12-21HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024702561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024702561008500247025618500247025610850024702561

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
945017205
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850024702523SkyOPSS00062026-05-11
00850024702530SkyOPSS00092026-05-11
00850024702554SkyOPSS00152026-05-07
00850024702578SkyOPSS00222026-05-07
00850024702004SkyOPSP0001L2024-09-23
00850024702011SkyOPSP0001R2024-09-23
00850024702028SkyOPSP00022024-09-23
00850024702035SkyOPSP0003L 2024-09-23
00850024702042SkyOPSP0003R 2024-09-23
00850024702059SkyOPS24-008-N2024-09-23
00850024702066SkyOPS24-010-N2024-09-23
00850024702073SkyOPS24-012-N2024-09-23
00850024702080SkyOPS24-014-N2024-09-23
00850024702097SkyOPS24-016-N2024-09-23
00850024702103SkyOPS24-018-N2024-09-23
00850024702110SkyOPS24-020-N2024-09-23
00850024702127SkyOPS24-022-N2024-09-23
00850024702134SkyOPS24-024-N2024-09-23
00850024702141SkyOPS24-026-N2024-09-23
00850024702158SkyOPS24-028-N2024-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24
00724995237080V. MuellerSteris CorporationKCT2026-09-24
00724995237097V. MuellerSteris CorporationKCT2026-09-24
00724995237103V. MuellerSteris CorporationKCT2026-09-24
00724995237110V. MuellerSteris CorporationKCT2026-09-24
00724995237127V. MuellerSteris CorporationKCT2026-09-24
00724995237134V. MuellerSteris CorporationKCT2026-09-24
00724995237141V. MuellerSteris CorporationKCT2026-09-24
00724995237158V. MuellerSteris CorporationKCT2026-09-24
00724995237165V. MuellerSteris CorporationKCT2026-09-24
00724995237172V. MuellerSteris CorporationKCT2026-09-24
00724995237189V. MuellerSteris CorporationKCT2026-09-24
00724995237196V. MuellerSteris CorporationKCT2026-09-24
00724995237202V. MuellerSteris CorporationKCT2026-09-24
00724995237219V. MuellerSteris CorporationKCT2026-09-24
00724995237226V. MuellerSteris CorporationKCT2026-09-24
00724995237233V. MuellerSteris CorporationKCT2026-09-24
00724995237240V. MuellerSteris CorporationKCT2026-09-24
00724995237257V. MuellerSteris CorporationKCT2026-09-24
00724995237264V. MuellerSteris CorporationKCT2026-09-24
00724995237271V. MuellerSteris CorporationKCT2026-09-24
00724995237288V. MuellerSteris CorporationKCT2026-09-24
00724995237295V. MuellerSteris CorporationKCT2026-09-24
00724995237301V. MuellerSteris CorporationKCT2026-09-24