Spinal Manometer NRFit 001163-38F

GUDID 04048223029770

Spinal Manometer NRFit Manometer Set, erile

Pajunk GmbH Medizintechnologie

Cerebrospinal fluid manometer, mechanical
Primary Device ID04048223029770
NIH Device Record Keye3058481-f32a-41fc-b8ac-9a9e81cc28f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpinal Manometer NRFit
Version Model Number001163-38F
Catalog Number001163-38F
Company DUNS317654283
Company NamePajunk GmbH Medizintechnologie
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com
Phone+1(888)972-5865
Emailinfo@pajunk-usa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223029770 [Unit of Use]
GS104048223049860 [Primary]
GS114048223029777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMJMANOMETER, SPINAL-FLUID

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-14
Device Publish Date2020-07-06

Devices Manufactured by Pajunk GmbH Medizintechnologie

04048223128817 - SPROTTE®2025-09-25 SPROTTE® 25G x 3 1/2" (90mm) with magnification and Introducer, sterile
04048223129111 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 25G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129517 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 25G x 4" (103mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129647 - SPROTTE®2025-09-25 SPROTTE® 22G x 2" (50mm), sterile
04048223129678 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 22G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile
04048223129692 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 27G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129838 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 25G x 6" (150mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129999 - Standard Sprotte Needle2025-09-25 Standard Sprotte Needle 25G x 3 1/2" (90mm), sterile with Introducer and wings
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