DEVICE: InfiltraLong 420 (04048223131022)
Device Identifier (DI) Information
InfiltraLong 420
001158-00Z
In Commercial Distribution
001158-00Z
Pajunk GmbH Medizintechnologie
001158-00Z
In Commercial Distribution
001158-00Z
Pajunk GmbH Medizintechnologie
InfiltraLong 420 InfiltraLong catheter 19G x 420mm with integrated metal spiral with 15 drill
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? |
---|---|---|---|---|
46383 | Peripheral anaesthesia catheter set, non-medicated |
A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BSO | CATHETER, CONDUCTION, ANESTHETIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K080675 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
f5665e76-09a0-4cd7-b3f9-ba95f3b8bd32
June 26, 2025
2
June 17, 2025
June 26, 2025
2
June 17, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04048223132401 | 10 | 04048223131022 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 770-493-6832
info@pajunk-usa.com
info@pajunk-usa.com