DEVICE: TRANSFORM (07613327004472)
Device Identifier (DI) Information
TRANSFORM
M003SRC05150
In Commercial Distribution
SRC0515
Stryker Corporation
M003SRC05150
In Commercial Distribution
SRC0515
Stryker Corporation
C Compliant Occlusion Balloon Catheter
Device Characteristics
Labeling does not contain MRI Safety Information | |
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 |
---|---|
Intravascular occluding catheter, image-guided | A sterile flexible tube with an inflatable balloon(s) at the distal end intended to be introduced under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and neurovasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. It is intended for short-term use only. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MJN | Catheter, intravascular occluding, temporary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K122576 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in cool, dry, dark place. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Balloon Outer Diameter: 5.0 Millimeter |
Length: 15.0 Millimeter |
Device Record Status
c80325aa-9389-48ec-9f55-5edfec18b417
July 06, 2018
3
September 21, 2016
July 06, 2018
3
September 21, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)916-3876
NVCustomerService@stryker.com
NVCustomerService@stryker.com