DEVICE: Surgilube (00851809002449)

Device Identifier (DI) Information

Surgilube
281020536
In Commercial Distribution
281020536
HR PHARMACEUTICALS INC.
00851809002449
GS1

1
828918164 *Terms of Use
Sterile Surgical Lubricant, Metal Tube
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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?
60796 General-body orifice lubricant
A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.
Active false
60795 Multi-purpose surgical instrument lubricant
A sterile substance intended to be applied to a sterile surgical instrument prior to use for device mechanical and patient lubrication purposes (e.g., to facilitate moving parts of device, and to facilitate movement between instrument and patient); it is not dedicated to a specific type of surgical instrument. It includes plant-derived materials (e.g., glycerin) and may also be intended for non-surgical applications (e.g., entry of a device into a body orifice). After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KMJ Lubricant, patient
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Liquid Chemical
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Weight: 120.49 Gram
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Device Record Status

19f0258c-9a75-4bf8-8fa7-170b9d4a0453
June 17, 2024
3
August 27, 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
10851809002446 12 00851809002449 In Commercial Distribution Box
20851809002443 6 10851809002446 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
NDC/NHRIC 00281020536
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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

[?]
+1(717)252-1110 109
chris.wiesman@hrpharma.com
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