FDA.reportPublic FDA data

Omnia Medical PsiF 90

Primary DI
00843511123352
Brand
Omnia Medical PsiF 90
Company
OMNIA MEDICAL, LLC
Model
22-5P-IMP1
Device description
PsiF 90 Impactor Single Use Aluminum
Published
2024-06-12
Public version status
Update
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
00843511123352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511123352008435111233528435111233520843511123352

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511102852Omnia Medical TiBrid™-TS09-0P-102609-152026-08-18
00843511102869Omnia Medical TiBrid™-TS09-0P-102610-152026-08-18
00843511102876Omnia Medical TiBrid™-TS09-0P-102611-152026-08-18
00843511102883Omnia Medical TiBrid™-TS09-0P-102612-152026-08-18
00843511102890Omnia Medical TiBrid™-TS09-0P-102613-152026-08-18
00843511102906Omnia Medical TiBrid™-TS09-0P-102614-152026-08-18
00843511102913Omnia Medical TiBrid™-TS09-0P-102615-152026-08-18
00843511102920Omnia Medical TiBrid™-TS09-0P-102616-152026-08-18
00843511102586Omnia Medical TiBrid™-TS09-0P-102208-102026-08-03
00843511102593Omnia Medical TiBrid™-TS09-0P-102209-102026-08-03
00843511102609Omnia Medical TiBrid™-TS09-0P-102210-102026-08-03
00843511102616Omnia Medical TiBrid™-TS09-0P-102211-102026-08-03
00843511102623Omnia Medical TiBrid™-TS09-0P-102212-102026-08-03
00843511102630Omnia Medical TiBrid™-TS09-0P-102213-102026-08-03
00843511102647Omnia Medical TiBrid™-TS09-0P-102214-102026-08-03
00843511102654Omnia Medical TiBrid™-TS09-0P-102215-102026-08-03
00843511102661Omnia Medical TiBrid™-TS09-0P-102216-102026-08-03
00843511102678Omnia Medical TiBrid™-TS09-0P-102209-152026-08-03
00843511102685Omnia Medical TiBrid™-TS09-0P-102210-152026-08-03
00843511102692Omnia Medical TiBrid™-TS09-0P-102211-152026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03