DEVICE: Occlutech® Steerable Guiding Sheath (07350048971156)
Device Identifier (DI) Information
Occlutech® Steerable Guiding Sheath
51GS014
Not in Commercial Distribution
51GS014
Oscor Inc.
51GS014
Not in Commercial Distribution
51GS014
Oscor Inc.
Steerable Guiding Sheath, 14F
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
17846 | Vascular guide-catheter, single-use |
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. 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 [?] |
---|---|
K120459 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Outer Diameter 16.8F (5.60 mm) |
Device Size Text, specify: Sheath Usable Length 71 cm |
Lumen/Inner Diameter: 4.5 Millimeter |
Device Size Text, specify: Dilator Usable Length 89 cm |
Device Size Text, specify: Sheath Overall Length 86 cm |
Device Size Text, specify: Dilator Overall Length 93 cm |
Device Record Status
64ad6282-f4d9-4026-9246-b4a8f6c481ea
December 22, 2021
8
November 28, 2017
December 22, 2021
8
November 28, 2017
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(727)937-2511
sales@oscor.com
sales@oscor.com