SPROTTE® 321163-31A
GUDID 04048223113820
Needle
Pajunk GmbH Medizintechnologie
Spinal needle, single-use| Primary Device ID | 04048223113820 |
| NIH Device Record Key | 027c3206-31d6-4f70-b9b8-b0405f30efc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPROTTE® |
| Version Model Number | 321163-31A |
| Catalog Number | 321163-31A |
| Company DUNS | 317654283 |
| Company Name | Pajunk GmbH Medizintechnologie |
| Device Count | 25 |
| 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 | false |
| 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 | |
| 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 | |
| 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
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
| Length | 90 Millimeter |
| Outer Diameter | 0.8 Millimeter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 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 | 04048223066447 [Previous] |
| GS1 | 04048223113820 [Unit of Use] |
| GS1 | 04048223116630 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160294
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 | 2022-03-03 |
| Device Publish Date | 2022-02-23 |
On-Brand Devices [SPROTTE®]
| 14048223031978 | SPROTTE® 25G x 35mm with IntroDucer 10mm, sterile |
| 14048223031961 | SPROTTE® 24G x 50mm with Introducer 15mm sterile |
| 14048223017842 | SPROTTE® 25G x 1 3/8" (35mm), sterile |
| 14048223016203 | SPROTTE® 24G x 1 3/8" (35mm), sterile |
| 14048223014292 | SPROTTE® 22G x 6", w. stylet, sterile |
| 14048223014285 | SPROTTE® 22G x 4 3/4", w. stylet sterile |
| 14048223014018 | SPROTTE® 22G x 3 1/2", w. stylet sterile |
| 14048223003111 | SPROTTE® 22G x 2" (50mm), sterile |
| 14048223001957 | SPROTTE® 27G x 6", with Introducer, sterile |
| 14048223001919 | SPROTTE® 27G x 2 3/4" (70mm), sterile with Introduc |
| 14048223001858 | SPROTTE® 24G x 8" (200mm), with Introduc |
| 14048223001742 | SPROTTE® effect 25G x 3 1/2" (90mm), sterile |
| 14048223001636 | SPROTTE® effect 27G x 123mm,sterile |
| 14048223001612 | SPROTTE® effect 27G x 4 3/4" (120mm),sterile, with Introduc |
| 14048223001605 | SPROTTE® effect 25G x 3 1/2" (90mm), sterile with Introduc |
| 14048223001599 | SPROTTE® effect 25G x 4" (103mm), sterile, with Introduc |
| 14048223001582 | SPROTTE® effect 25G x 4 3/4" (120mm),sterile, with Introduc |
| 14048223001575 | SPROTTE® effect 27G x 4" (103mm), sterile, with Introduc |
| 14048223001506 | SPROTTE® 22G x 8" (200mm), with Introduc |
| 14048223001469 | SPROTTE® 25G x 6" (150mm), sterile, with Introduc |
| 14048223001438 | SPROTTE® effect 27G x 3 1/2" (90mm), sterile, with Introduc |
| 14048223000875 | SPROTTE® 22G x 4" (103mm), sterile |
| 14048223000868 | SPROTTE® 24G x 4" (103mm), sterile |
| 14048223000844 | SPROTTE® 25G x 3 1/2" (90mm), sterile |
| 14048223000837 | SPROTTE® effect 29G x 3 1/2" (90mm) with Introduc |
| 14048223000813 | SPROTTE® 22G x 4" (103mm), sterile, with Introduc |
| 14048223000790 | SPROTTE® 25G x 123mm, sterile |
| 14048223000776 | SPROTTE® 22G x 6" (150mm),sterile, with Introduc |
| 14048223000769 | SPROTTE® 24G x 6" (150mm), sterile |
| 14048223000707 | SPROTTE® 22G x 4¾" (120mm),sterile, with Introdu |
| 14048223000691 | SPROTTE® 24G x 6" (150mm),sterile, with Introduc |
| 14048223000653 | SPROTTE® 24G x 3 1/2" (90mm), sterile, with Introduc |
| 14048223000615 | SPROTTE® 24G x 123mm, sterile, |
| 14048223000592 | SPROTTE® 22G x 1" (25mm), sterile |
| 14048223000578 | SPROTTE® 22G x 2 3/4" (70mm), sterile |
| 14048223000561 | SPROTTE® 22G x 2 3/4" (70mm), sterile, with Introduc |
| 14048223000554 | SPROTTE® 25G x 4 3/4" (120mm), sterile, with Introduc |
| 14048223000523 | SPROTTE® 22G x 6" (150mm), sterile |
| 14048223000516 | SPROTTE® 24G x 4 3/4" (120mm),sterile, with Introduc |
| 14048223000509 | SPROTTE® 25G x 4" (103mm), sterile with Introduc |
| 14048223000455 | SPROTTE® 22G x 4 3/4" (120mm), sterile |
| 14048223000448 | SPROTTE® 24G x 4 3/4" (120mm),sterile |
| 14048223000424 | SPROTTE® 25G x 4 3/4" (120mm), sterile |
| 14048223000295 | SPROTTE® 22G x 3 1/2" (90mm), sterile, with Introduc |
| 14048223000288 | SPROTTE® 24G x 2 3/4" (70mm), sterile, with Introduc |
| 14048223000271 | SPROTTE® 24G x 4"(103mm), sterile, with Introduc |
| 14048223000264 | SPROTTE® 25G x 2 3/4" (70mm), sterile with Introduc |
| 14048223000257 | SPROTTE® 25G x 3 1/2" (90mm), sterile, with Introduc |
| 14048223000066 | SPROTTE® 24G x 1" (25mm), sterile |
| 14048223000059 | SPROTTE® 22G x 3 1/2" (90mm), 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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