DEVICE: Pointer Excel II (14897076720054)

Device Identifier (DI) Information

Pointer Excel II
ED3988
In Commercial Distribution
ED3988
TENS PLUS INDUSTRIAL COMPANY
14897076720054
GS1

1
663211978 *Terms of Use
Pointer Excel II is the latest and most advanced user friendly stimulator. Features a built-in, 0.35" x 1.0" LCD digital meter which displays both frequency and location. Unit features two grounding plates on the unit (allowing use with either left or right hands) as well as a hand probe with grounding pole and attached wire. Two probe tips are included with unit: ear 2 mm (0.08") and body 4 mm (0.16"). Other standard accessories include 9 volt battery, carrying case, and instructions.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
35372 Analgesic transcutaneous electrical nerve stimulation system
An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
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FDA Product Code

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Product Code Product Code Name
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K060517 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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

029d0ad0-aff2-46df-94db-78d4622119f6
October 23, 2019
4
August 04, 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
34897076720058 30 14897076720054 In Commercial Distribution Master Case
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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)

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None
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Production Identifier(s) in UDI

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Customer Contact

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800-722-8775
customerservice@lhasaoms.com
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