DEVICE: SJM™ (05414734026567)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47766 | Haemostasis valve obturator |
A sterile device designed to seal the sheath of a haemostasis valve to maintain sheath patency (i.e., to prevent blood from coagulating in the sheath and blocking access through the haemostasis valve). It is typically a long, thin, rod-like device made of plastic with a rounded distal tip and a cap at the proximal end; it is available in a variety of sizes (e.g., 4-13 French and 15-26 cm long). The proximal cap has a locking mechanism (e.g., a Luer-lock or snap lock) to hold it securely in place to prevent blood loss from the patient. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | INTRODUCER, CATHETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K884494 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a cool, dark, dry place. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 15 Centimeter |
Catheter Gauge: 5 French |
Device Record Status
facd4258-7291-4d25-a466-a484b2ec10c9
July 06, 2018
3
September 15, 2015
July 06, 2018
3
September 15, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15414734026564 | 10 | 05414734026567 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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)478-5833
customerservice@sjm.com
customerservice@sjm.com