FDA.reportPublic FDA data

N/A

Primary DI
00817438023897
Brand
N/A
Company
Omega Surgical Instruments Inc
Model
ORS-101NS
Device description
31.5 MM X 1.02 MM STERNUM RECIPROCATING BLADE (NON-STERILE)
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817438023897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817438023897008174380238978174380238970817438023897

GMDN Terms#

Term, Definition table
TermDefinition
Sternum saw blade, single-useA flat metal surgical instrument with a serrated edge intended to be attached to a dedicated powered surgical saw for cutting the sternum (the breastbone) during cardiovascular surgery. It is available in various forms (e.g., straight or arc-shaped) and is powered by a rapid reciprocating, oscillating or sagittal motion provided by the saw. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
8106959800complaints@omegasurgical.com

Regulatory Flags#

DUNS number
808825038
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817438028618N/AOZD-21200-022026-03-03
00817438028106N/AMR10BA502026-02-09
00817438028113N/AMR10MH302026-02-09
00817438028656N/AMR10BA50D2026-02-09
00817438028663N/AMR10BA602026-02-09
00817438028137N/AMR14BA40D2025-11-13
00817438028144N/AMR14BA502025-11-13
00817438028151N/AMR14BA602025-11-13
00817438028632N/AMR14BA302025-11-13
00817438028649N/AMR14BA30D2025-11-13
00817438028625N/AES-FA2-0232025-11-03
00817438028373N/AMRF18TA152025-10-15
00817438028540N/ASM-35142025-09-09
00817438028571N/ASS-35142025-09-09
00817438028588N/AZMS-35142025-09-09
00817438028502N/APTR-3245-02R2025-08-19
00817438028427N/APTR-3270-042024-10-09
00817438028595N/ASM-30582025-07-23
00817438028601N/AZMS-30582025-07-23
00817438028090N/AMR10BA40D2025-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800053401531SharkCutTechcord co.,LtdGFA2024-04-16
08800053401548SharkCutTechcord co.,LtdGFA2024-04-16
08800053401586SharkCutTechcord co.,LtdGFA2024-04-16
08800053401593SharkCutTechcord co.,LtdGFA2024-04-16
08800053401616SharkCutTechcord co.,LtdGFA2024-04-16
08800053401623SharkCutTechcord co.,LtdGFA2024-04-16
08800053401647SharkCutTechcord co.,LtdGFA2024-04-16
08800053401654SharkCutTechcord co.,LtdGFA2024-04-16
08800053401678SharkCutTechcord co.,LtdGFA2024-04-16
08800053401692SharkCutTechcord co.,LtdGFA2024-04-16
08800053401142SharkCutTechcord co.,LtdGFA2024-04-15
08800053401159SharkCutTechcord co.,LtdGFA2024-04-15
08800053401166SharkCutTechcord co.,LtdGFA2024-04-15
08800053401173SharkCutTechcord co.,LtdGFA2024-04-15
08800053401180SharkCutTechcord co.,LtdGFA2024-04-15
08800053401197SharkCutTechcord co.,LtdGFA2024-04-15
08800053401203SharkCutTechcord co.,LtdGFA2024-04-15
08800053401210SharkCutTechcord co.,LtdGFA2024-04-15
08800053401227SharkCutTechcord co.,LtdGFA2024-04-15
08800053401234SharkCutTechcord co.,LtdGFA2024-04-15
08800053401241SharkCutTechcord co.,LtdGFA2024-04-15
08800053401258SharkCutTechcord co.,LtdGFA2024-04-15
08800053401289SharkCutTechcord co.,LtdGFA2024-04-15
08800053401296SharkCutTechcord co.,LtdGFA2024-04-15
08800053401302SharkCutTechcord co.,LtdGFA2024-04-15
08800053401319SharkCutTechcord co.,LtdGFA2024-04-15
08800053401326SharkCutTechcord co.,LtdGFA2024-04-15
08800053401333SharkCutTechcord co.,LtdGFA2024-04-15
08800053401340SharkCutTechcord co.,LtdGFA2024-04-15
08800053401357SharkCutTechcord co.,LtdGFA2024-04-15