DEVICE: N/A (00858965006175)

Device Identifier (DI) Information

N/A
TDL108
In Commercial Distribution
N/A
PAJUNK MEDICAL SYSTEMS, LP
00858965006175
GS1

1
136718553 *Terms of Use
SonoLong Sono Tray 18G x 2'' (50mm) echogenic needle with Tuohy tip, 60cm injection tubing, 60cm stimulation cable, SonoLong Sono 20G x 20'' (50cm) echogenic catheter with closed tip and 3 lateral openings, catheter container with introducer aid, 30cm graduation, helical coil, steel stylet, clamping adapter
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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?
64347 Peripheral anaesthesia catheter set, medicated
A collection of devices intended for the continuous-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent, an anaesthesia catheter, and an anaesthesia needle usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OGJ Nerve Block Tray
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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

f400a50c-3692-4407-86d2-e9682d2b453d
January 24, 2024
1
January 16, 2024
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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
20858965006179 10 00858965006175 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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