DEVICE: N/A (00858965006908)

Device Identifier (DI) Information

N/A
TBL404
In Commercial Distribution
N/A
PAJUNK MEDICAL SYSTEMS, LP
00858965006908
GS1

1
136718553 *Terms of Use
Sprotte 20Gx90mm Lumbar Puncture Tray
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
Yes
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?
12404 Lumbar puncture kit
A collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PWY Lumbar Puncture Tray (Adult & Pediatric)
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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
No storage/handling found
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Clinically Relevant Size

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

9eabb559-1978-4c9c-ade3-696da58fe588
March 17, 2025
1
March 07, 2025
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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
20858965006902 10 00858965006908 In Commercial Distribution N/A
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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
No
No CLOSE

Customer Contact

[?]
770-493-6832
info@pajunk-usa.com
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