FDA.reportPublic FDA data

Omnia Medical PsiF

Primary DI
00843511100643
Brand
Omnia Medical PsiF
Company
OMNIA MEDICAL, LLC
Model
01-01-0012
Catalog number
01-01-0012
Device description
PsiF Slap Hammer Peg Instrument
Published
2020-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00843511100643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511100643008435111006438435111006430843511100643

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mallet headA device intended to replace the head of some types of surgical mallets and hammers. It is typically a solid cylinder of various diameters with flat ends; it is made of durable, non-splintering, synthetic polymer materials and is fixed (typically screwed using it's central screw thread) to the the distal end of the mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511128777Omnia Medical TiBrid™-A/SA14-5A-QAT114-5A-QAT12026-06-01
00843511128388Omnia Medical TiBrid™- A/SA 17-5A-BL0617-5A-BL062026-05-11
00843511128395Omnia Medical TiBrid™- A/SA 17-5A-BL082026-05-11
00843511128401Omnia Medical TiBrid™- A/SA 17-5A-BL102026-05-11
00843511128418Omnia Medical TiBrid™- A/SA 17-5A-BL122026-05-11
00843511128425Omnia Medical TiBrid™- A/SA 17-5A-BL142026-05-11
00843511128432Omnia Medical TiBrid™- A/SA 17-5A-BL162026-05-11
00843511128463Omnia Medical TiBrid™- A/SA 17-5A-AWL1-B2026-05-11
00843511128494Omnia Medical TiBrid™-C07-5C-LTDE2026-05-11
00843511128500Omnia Medical Instruments99-5A-CL132026-05-11
00843511128517Omnia Medical Instruments99-5A-CL202026-05-11
00843511128548Omnia Medical Golden Spike OM-TLS4015-T2026-05-11
00843511128555Omnia Medical Golden Spike OM-TLS4016-T2026-05-11
00843511128562Omnia Medical Golden Spike OM-TLS4017-T2026-05-11
00843511128579Omnia Medical Golden Spike OM-TLS4018-T2026-05-11
00843511128586Omnia Medical Golden Spike OM-TLS4019-T2026-05-11
00843511128593Omnia Medical Golden Spike OM-TLS4020-T2026-05-11
00843511128609Omnia Medical Golden Spike OM-TLS4021-T2026-05-11
00843511128616Omnia Medical Golden Spike OM-TLS4022-T2026-05-11
00843511128623Omnia Medical Golden Spike OM-TLS4023-T2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03