DEVICE: Implant Kit (08056646500840)

Device Identifier (DI) Information

Implant Kit
12.XYYYY.00
In Commercial Distribution

OMNIA SRL
08056646500840
GS1

1
447696675 *Terms of Use
The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use by specialized personnel and are composed of consumables and devices intended for the preparation of the operating field, maintenance of cleanliness (ensuring the hygiene of the field and limiting the risk of contamination) and the performance of various types of surgery. The devices provided can be: - non-invasive devices, for the preparation of the operating field - for example: drapes, gowns, masks and accessories (bandages, sheaths, tool pockets, bags for collecting liquids, fixed pliers for drapes, etc.) - invasive surgical devices for temporary use not in contact with the central circulatory system and with the nervous system - for example: needles and syringes with needle, disposable scalpels and gauze. - devices for channeling liquids intended for irrigation. Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model number : X = alphabetic character YYYY=n° of 4 number character.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
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?
33961 General surgical procedure kit, non-medicated, single-use
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LRO General Surgery Tray
KKX Drape, Surgical
FYA Gown, Surgical
FXX Mask, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110724 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

64993a50-faf7-43fc-aaeb-0a72291b34cf
June 17, 2022
3
February 04, 2020
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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

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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

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No Customer Contact currently defined
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