DEVICE: SIGNACREME (00855683006241)

Device Identifier (DI) Information

SIGNACREME
ELECTRODE CREAM
In Commercial Distribution
17-20
PARKER LABORATORIES INC
00855683006241
GS1

1
002449593 *Terms of Use
SIGNACREME ELECTRODE CREME 1/2 GAL BOTTLE.
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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
Electrode gel A medium for transmission of electrical signals between an electrode and the body and for reduction of isolation ability of the skin. It is usually used in conjunction with electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
GYB Media, Electroconductive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K782055 000
No 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

3f0e966b-128a-4c4a-accd-602e7afeb385
July 06, 2018
3
July 05, 2017
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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
20855683006245 4 10855683006248 In Commercial Distribution BOX
10855683006248 1 00855683006241 In Commercial Distribution BOX
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
973-276-9500
customerservice@parkerlabs.com
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