DEVICE: NA (10705034787169)

Download: XML | JSON

Device Identifier (DI) Information

NA
497.086
497086
SYNTHES (U.S.A.) LP
10705034787169
GS1
1
TI INFERIOR CRADLE-SIZE 5 70MM RADIUS
CLOSE

Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vertical expandable prosthetic rib system An assembly of implantable devices designed to treat a patient with complex chest wall and/or spinal deformities, typically thoracic insufficiency syndrome (TIS) in paediatric patients (a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development). The assembly typically consists of telescoping rods/bars, fixation hooks, and locking screws/clamps made of surgical stainless steel or titanium (Ti), and are typically vertically attached to the ribs, spine, and/or pelvis to help straighten the spine and separate ribs so that the lungs can grow and fill with sufficient air for breathing.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MDI Prosthesis, rib replacement
CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 14, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC H9814970860
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
CLOSE