FDA.reportPublic FDA data

NA

Primary DI
10886982238115
Brand
NA
Company
Synthes GmbH
Model
511.904
Catalog number
511904
Device description
STERNUM TOP FOR RECIPROCATING SAW ATTACHMENT
Published
2016-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07611819118768Direct MarkingGS10
10886982238115PrimaryGS10
H6795119040SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819118768076118191187687611819118768
1088698223811510886982238115

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982195937NA357.2223572222017-02-20
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26
10886982064806NA03.000.076S03000076S2016-06-30
10886982065056NA03.000.122S03000122S2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227421Saw BladeTreace Medical Concepts, Inc.GFA2026-08-25
00810111227445Saw BladeTreace Medical Concepts, Inc.GFA2026-08-25
37630055512506Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
37630055512537Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
37630055512568Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512503Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512534Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512565Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512509Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512530Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512561Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
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