DEVICE: SJM™ (05414734400138)

Device Identifier (DI) Information

SJM™
1115
Not in Commercial Distribution
1115
ADVANCED NEUROMODULATION SYSTEMS, INC.
05414734400138
GS1
March 28, 2018
1
021675699 *Terms of Use
Epidural Needle, 15 gauge, 4" (10cm)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Epidural needle, non-threaded A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
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Clinically Relevant Size

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Size Type Text
Needle Gauge: 15 Gauge
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Device Record Status

69570536-6023-4229-b703-ab6911a5c126
April 30, 2018
4
October 23, 2014
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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
15414734400135 5 05414734400138 2018-03-28 Not in Commercial Distribution
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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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