DEVICE: Capella™ (00821329400339)

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Device Record History
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Device Identifier (DI) Information
Capella™
1012868-005
In Commercial Distribution
MK5182
Greatbatch Ltd
00821329400339
GS1

1
968623467 *Terms of Use
5 French Coaxial Micro-Introducer Kit
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
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?
58865 Vascular catheter introduction set, nonimplantable
A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DYB Introducer, Catheter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: .018" [.47 mm] SS/AuW Straight Tip Guidewire 45.0 cm
Device Size Text, specify: Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
Device Size Text, specify: Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
Device Size Text, specify: 5 F Sheath 0.9 mm ID, 9.3 cm Length
Length: 9.3 Centimeter
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Device Record Status
8a73c8bf-1b1b-4572-8531-780034ec791d
March 20, 2024
5
April 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10821329400336 10 00821329400339 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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