DEVICE: Anmuth Medical International (08403207008992)

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Device Record History
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Device Identifier (DI) Information
Anmuth Medical International
38-950-03
In Commercial Distribution
38-950-03
Anmuth Medical International, LLC
08403207008992
GS1

1
786500830 *Terms of Use
BUNNELL Tendon Stripper Fig 3 15cm/6"
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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?
35380 Tendon stripper
A hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HRT STRIPPER, SURGICAL
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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
Length: 6 Inch
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Device Record Status
7af6168b-89bc-4ccc-aec1-a8ca7e3078f3
February 03, 2025
1
January 24, 2025
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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(413)478-9876
marc@anmuthmedical.com
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