FDA.reportPublic FDA data

Omnia Medical PsiF 90

Primary DI
00843511127749
Brand
Omnia Medical PsiF 90
Company
OMNIA MEDICAL, LLC
Model
22-7P-P901
Device description
PsiF 90 Surgery Ready Tray
Published
2024-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511127749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511127749008435111277498435111277490843511127749

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, single-useA 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 is in the form of a shallow receptacle with a raised rim and moulded positions for placing the instruments. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511102135Omnia Medical TiBrid™-TC08-0T-2707-72026-07-22
00843511102142Omnia Medical TiBrid™-TC08-0T-2708-708-0T-2708-72026-07-22
00843511102159Omnia Medical TiBrid™-TC08-0T-2709-708-0T-2709-72026-07-22
00843511102166Omnia Medical TiBrid™-TC08-0T-2710-708-0T-2710-72026-07-22
00843511102173Omnia Medical TiBrid™-TC08-0T-2711-708-0T-2711-72026-07-22
00843511102180Omnia Medical TiBrid™-TC08-0T-2712-708-0T-2712-72026-07-22
00843511102197Omnia Medical TiBrid™-TC08-0T-2713-708-0T-2713-72026-07-22
00843511102203Omnia Medical TiBrid™-TC08-0T-2714-708-0T-2714-72026-07-22
00843511102210Omnia Medical TiBrid™-TC08-0T-2715-708-0T-2715-72026-07-22
00843511102227Omnia Medical TiBrid™-TC08-0T-2716-708-0T-2716-72026-07-22
00843511102234Omnia Medical TiBrid™-TC08-0T-3107-708-0T-3107-72026-07-22
00843511102241Omnia Medical TiBrid™-TC08-0T-3108-708-0T-3108-72026-07-22
00843511102258Omnia Medical TiBrid™-TC08-0T-3109-708-0T-3109-72026-07-22
00843511102265Omnia Medical TiBrid™-TC08-0T-3110-708-0T-3110-72026-07-22
00843511102272Omnia Medical TiBrid™-TC08-0T-3111-708-0T-3111-72026-07-22
00843511102289Omnia Medical TiBrid™-TC08-0T-3112-708-0T-3112-72026-07-22
00843511102296Omnia Medical TiBrid™-TC08-0T-3113-708-0T-3113-72026-07-22
00843511102302Omnia Medical TiBrid™-TC08-0T-3114-708-0T-3114-72026-07-22
00843511102319Omnia Medical TiBrid™-TC08-0T-3115-708-0T-3115-72026-07-22
00843511102326Omnia Medical TiBrid™-TC08-0T-3116-708-0T-3116-72026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17