DEVICE: Surgical Claw angled (09008737002848)

Device Identifier (DI) Information

Surgical Claw angled
00284
In Commercial Distribution

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09008737002848
GS1

1
300764032 *Terms of Use
Reusable Surgical Tool
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
61446 Cochlear electrode array introducer, reusable
A non-sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin probe with a clawed distal end mounted on a handle and is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MCM Implant, Cochlear
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P000025 005
P000025 014
P000025 021
P000025 050
P000025 070
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

de226c37-fc27-4bb7-85ed-e0a1b4a10fbd
September 15, 2022
5
September 22, 2014
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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
No Package DIs found
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Secondary DI

[?]
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
No
No
No CLOSE

Customer Contact

[?]
+1(888)633-3524
implants.us@medel.com
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