DEVICE: Axiom® Lig-A-Loops® (M6651110)

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Device Record History
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Device Identifier (DI) Information
Axiom® Lig-A-Loops®
111
In Commercial Distribution

AXIOM MEDICAL, INCORPORATED
M6651110
HIBCC

1
094439676 *Terms of Use
Retraction Tape, Maxi, Red, Arteries
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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?
46242 Surgical support tape, non-bioabsorbable
A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
KDC Instrument, Surgical, Disposable
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K800015 000
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
No Device Sizes
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Device Record Status
b454cc39-69c7-4beb-8e6a-379ba5496925
September 10, 2019
2
September 23, 2018
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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
M6651115 60 M6651113 In Commercial Distribution Carton
M6651113 10 M6651111 In Commercial Distribution Case
M6651111 10 M6651110 In Commercial Distribution Box
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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
Yes
No
No CLOSE

Customer Contact

[?]
310-533-9020
Sales@AxiomMed.com
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