DEVICE: OptiSeal™ (00821329000904)

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Device Record History
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Device Identifier (DI) Information
OptiSeal™
1000093-020
In Commercial Distribution
7445
Greatbatch Ltd
00821329000904
GS1

1
968623467 *Terms of Use
Valved Peelable PTFE Introducer
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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: Syringe Total Volume: 12 milliliter
Device Size Text, specify: Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
Device Size Text, specify: Guidewire OD: 0.89 mm
Device Size Text, specify: Guidewire Length: 60 cm
Device Size Text, specify: Dilator OD: 3.9 mm
Device Size Text, specify: Sheath ID: 3.7 mm
Device Size Text, specify: Sheath Effective Length: 13 cm
Device Size Text, specify: Dilator ID: 0.9 mm
Catheter Gauge: 11 French
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Device Record Status
63ca0289-e598-46f1-baba-db54d314c03c
March 20, 2024
2
August 15, 2019
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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
20821329000908 5 00821329000904 In Commercial Distribution box
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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