FDA.reportPublic FDA data

Figure 8 Sternotomy Closure Device

Primary DI
10862376000322
Brand
Figure 8 Sternotomy Closure Device
Company
FIGURE 8 SURGICAL, INC.
Model
FP-20188
Device description
Shelf Box for Single Straps
Published
2017-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDQCerclage, Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10862376000322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086237600032210862376000322

GMDN Terms#

Term, Definition table
TermDefinition
Sternal fixation deviceA collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.

Contacts#

Phone, Email table
PhoneEmail
304-514-3414brianmiller32@gmail.com

Regulatory Flags#

DUNS number
078582803
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10862376000339Figure 8 Sternotomy Closure DeviceFP-201892017-12-20
00862376000301Figure 8 Sternotomy Closure Device20155FP-201552016-10-28
00862376000325Figure 8 Sternotomy Closure DeviceFP-201862017-12-20
00862376000332Figure 8 Sternotomy Closure DeviceFP-201872017-12-20
00862376000349Figure 8 Sternotomy Closure DeviceFP-201902017-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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