DEVICE: CauDal (04048223075265)

Device Identifier (DI) Information

CauDal
1149-12D025
In Commercial Distribution
1149-12D025
Pajunk GmbH Medizintechnologie
04048223075265
GS1

1
317654283 *Terms of Use
CauDal 23G x 25mm with Crawford tip 45° and plastic hub, with graduation
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
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?
58293 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BSP NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
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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 30 Degrees Celsius
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 23.0 Gauge
Length: 25.0 Millimeter
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Device Record Status

86b0e7cd-4e58-465a-aa32-f3a0d1c9adc6
February 07, 2025
1
January 30, 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
04048223054680 25 04048223075265 In Commercial Distribution
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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

[?]
+1 770-493-6832
info@pajunk-usa.com
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