DEVICE: MLCi2™ (05060191071024)

Device Identifier (DI) Information

MLCi2™
1525724
In Commercial Distribution

ELEKTA LIMITED
05060191071024
GS1

1
525557559 *Terms of Use
MLCi2
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Nitrous oxide/oxygen cylinder A container designed as a refillable cylinder used to hold a compressed mixture of 50% nitrous oxide (N2O) and 50% oxygen (O2) under safe conditions at high pressure (e.g., 50 - 150 Bar). It is typically filled with N2O/O2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote N2O/O2 content. The cylinder may be made of steel, aluminium (Al) or other non-ferrous materials and must be used together with a pressure regulator in order to release the N2O/O2 at the correct working pressure. N2O/O2 is used as a potent analgesic for acute trauma, dentistry and short painful procedures.
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FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, linear, medical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K082122 000
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Sterilization

No
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

7248e349-087f-48f9-bfa9-61bce1234688
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(855)693-5358
systems.support.na@elekta.com
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