DEVICE: Pharmaceutical Innovations (00300361500158)

Device Identifier (DI) Information

Pharmaceutical Innovations
Gentle Gel Lubricating Gel
In Commercial Distribution
36-1500-15
PHARMACEUTICAL INNOVATIONS INC
00300361500158
GS1

1
067486548 *Terms of Use
Gentle Gel Lubricating Gel: 150 ml tube
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
General-body orifice lubricant, non-sterile A non-sterile substance intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
MMS Lubricant, Vaginal, Patient
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FDA Premarket Submission

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

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

02835da5-7e63-40d7-a845-8ea257cb6f6d
March 29, 2018
2
September 14, 2016
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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
10300361500155 12 00300361500158 In Commercial Distribution
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Secondary DI

[?]
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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
973-242-2900
info@pharminnovations.com
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