FDA.report

N/A

Primary DI
00817438023903
Brand
N/A
Company
Omega Surgical Instruments Inc
Model
ORS-133
Device description
31.5 MM X 1.02 MM STERNUM RECIPROCATING BLADE
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817438023903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817438023903008174380239038174380239030817438023903

GMDN Terms

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
Radiation Sterilization

Contacts

PhoneEmail
8106959800complaints@omegasurgical.com

Regulatory Flags

DUNS number
808825038
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00817438028632N/AMR14BA302025-11-13
00817438028649N/AMR14BA30D2025-11-13
00817438028540N/ASM-35142025-09-09
00817438028571N/ASS-35142025-09-09
00817438028588N/AZMS-35142025-09-09
00817438028502N/APTR-3245-02R2025-08-19
00817438028595N/ASM-30582025-07-23
00817438028601N/AZMS-30582025-07-23
00817438028090N/AMR10BA40D2025-07-22
00817438028281N/AMR9AC752025-07-22
00817438028557N/AMR14BA50D2025-07-22
00817438028120N/AMR14BA402025-07-08

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