FDA.reportPublic FDA data

McKesson

Primary DI
20612479225286
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
174-OSS-3114
Device description
Saw blade, small bone, Oscillating
Published
2020-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102743000ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions Limited2011-01-20HWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479225286PrimaryGS10
10612479225272Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247922528620612479225286
1061247922527210612479225272

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, oscillating, single-useA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.

Regulatory Flags#

DUNS number
023904428
Device count
5
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B504OM22963414S70StrykerProvisionGFA2026-07-20
B504OM41251470900StrykerProvisionGFA2026-07-20
B504OM50711850Conmed LinvatecProvisionGFA2026-07-20
B504OM51003372330StrykerProvisionGFA2026-07-20
47630055517706Short Oscillating Blade 6x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517737Short Oscillating Blade 9x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517768Long Oscillating Blade 6x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055517799Long Oscillating Blade 9x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055519212Short Oscillating Blade 5x0.4mmBien-Air Surgery SAGFA2026-04-21
47630055519243Long Oscillating Blade 5x0.4mmBien-Air Surgery SAGFA2026-04-21
07613327576566PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576672PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576696PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576719PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576733PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576740PELLOSTRYKER CORPORATIONGFA2023-09-13
17630055512236Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512243Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512250Short Bullnose Blade 22x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512267Short Bullnose Blade 27x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512274Short Bullnose Blade 27x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512281Short Bullnose Blade 27x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512298Short Bullnose Blade 32x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512304Short Bullnose Blade 32x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512311Short Bullnose Blade 32x0.4mmBien-Air Surgery SAGFA2023-02-17
17630055512328Short Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512335Short Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512342Short Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512359Short Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2023-02-17
17630055512366Short Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2023-02-17