DEVICE: ELITE MEDICAL INSTRUMENTATION (G569EMIKTS3100)

Device Identifier (DI) Information

ELITE MEDICAL INSTRUMENTATION
EMI-KTS3-10
In Commercial Distribution
EMI-KTS3-10 RONGEUR
ELITE MEDICAL INSTRUMENTATION
G569EMIKTS3100
HIBCC

1
116733674 *Terms of Use
Kerrison, 40 Down, 1mm, Thin Footplate, 180mm
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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?
35541 Spinal rongeur
A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HFB Forceps, Biopsy, Gynecological
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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: 180 Millimeter
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Device Record Status

8f55d3aa-41a8-4dda-8b33-8a1d04bb2271
January 25, 2024
1
January 17, 2024
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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

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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)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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