DEVICE: EpiSpin II SAFETY (04048223072639)
Device Identifier (DI) Information
EpiSpin II SAFETY
0021451-30
In Commercial Distribution
0021451-30
Pajunk GmbH Medizintechnologie
0021451-30
In Commercial Distribution
0021451-30
Pajunk GmbH Medizintechnologie
EpiSpin II SAFETY Tuohy with backeye and wings 18G x 90cm, Sprotte Standard with
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? |
---|---|---|---|---|
46308 | Epidural/intrathecal anaesthesia set, non-medicated |
A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAZ | Anesthesia conduction kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
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Length: 90.0 Millimeter |
Needle Gauge: 18.0 Gauge |
Device Record Status
6a5a1a87-a245-4197-9b8b-1420d5e6c956
February 07, 2025
1
January 30, 2025
February 07, 2025
1
January 30, 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 |
---|---|---|---|---|---|
04048223052051 | 10 | 04048223072639 | 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