SPROTTE® 2.G 521251-30A
GUDID 04048223067703
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4" (103mm), sterile
Pajunk GmbH Medizintechnologie
Spinal needle, single-use| Primary Device ID | 04048223067703 |
| NIH Device Record Key | 03cef073-5129-4a71-8011-1fa4450a642e |
| Commercial Distribution Discontinuation | 2025-07-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SPROTTE® 2.G |
| Version Model Number | 521251-30A |
| Catalog Number | 521251-30A |
| Company DUNS | 317654283 |
| Company Name | Pajunk GmbH Medizintechnologie |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com | |
| Phone | +1 770-493-6832 |
| info@pajunk-usa.com |
Device Dimensions
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
| Needle Gauge | 24 Gauge |
| Length | 103 Millimeter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223067703 [Package] Contains: 04048223088289 Package: [25 Units] Discontinued: 2025-07-02 Not in Commercial Distribution |
| GS1 | 04048223088289 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241953
FDA Product Code
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-09 |
| Device Publish Date | 2025-07-01 |
On-Brand Devices [SPROTTE® 2.G]
| 14048223024376 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 3 1/2" |
| 14048223024352 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4 3/4" |
| 14048223024345 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 3 1/2" |
| 14048223024321 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4 3/4" |
| 14048223024307 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 3 1/2" |
| 14048223024291 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 4" (103 |
| 14048223024284 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 4 3/4" |
| 14048223024277 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 6" (150 |
| 14048223024260 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 3 1/2" |
| 14048223024253 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 4 3/4" |
| 14048223024239 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 123mm, |
| 14048223022822 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 4 3/4" |
| 14048223022815 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 4" (103 |
| 14048223022808 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 3 1/2" |
| 04048223067703 | SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4" (103mm), sterile |
Trademark Results [SPROTTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPROTTE 74257948 1741126 Live/Registered |
Pajunk GmbH 1992-03-23 |
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