AccessGUDID - DEVICE: SPROTTE® NRFit (04048223120866)

GUDID

Device Identifier (DI) Information

Brand Name: SPROTTE® NRFit
Version or Model: 121163-26A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 121163-26A
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223120866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: SPROTTE® NRFit 26G x 3 1/2" (90mm) with IntroDucer 0,80 x 30mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35212	Spinal needle, single-use	A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241953	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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
Length: 90.0 Millimeter
Needle Gauge: 26.0 Gauge

Device Record Status

Public Device Record Key: a9db51ad-9317-424b-b998-09fb7dc1a48b
Public Version Date: June 11, 2025
Public Version Number: 1
DI Record Publish Date: June 03, 2025