DEVICE: Aveta Max Disposable Resecting Device, 3.9 mm (00850006759323)
Device Identifier (DI) Information
Aveta Max Disposable Resecting Device, 3.9 mm
210-084
In Commercial Distribution
210-084
MEDITRINA, INC.
210-084
In Commercial Distribution
210-084
MEDITRINA, INC.
Aveta Max Disposable Resecting Device, 3.9 mm, for use with Aveta System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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46732 | Tissue morcellation system handpiece, line-powered |
A hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HIG | Insufflator, Hysteroscopic |
HIH | Hysteroscope (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K190372 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2d79de36-55e6-42f7-808f-a621264ba1a3
December 03, 2020
1
November 25, 2020
December 03, 2020
1
November 25, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00850006759354 | 3 | 00850006759323 | In Commercial Distribution | shelf carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined