FDA.reportPublic FDA data

N/A

Primary DI
20858965006872
Brand
N/A
Company
PAJUNK MEDICAL SYSTEMS, LP
Model
TBL401
Catalog number
N/A
Device description
Quincke 22Gx90mm Lumbar Puncture Tray
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWYLumbar Puncture Tray (Adult & Pediatric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWYLumbar Puncture Tray (Adult & Pediatric)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20858965006872PackageGS110In Commercial Distribution
00858965006878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085896500687220858965006872
00858965006878008589650068788589650068780858965006878

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar puncture kitA collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
136718553
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858965006939NATDLS250NA2025-08-28
50858965006934NATDLS250NA2025-08-28
00858965006922NATDLS217NA2025-07-07
50858965006927NATDLS217NA2025-07-07
00858965006892N/ATBL403N/A2025-03-07
00858965006908N/ATBL404N/A2025-03-07
20858965006896N/ATBL403N/A2025-03-07
20858965006902N/ATBL404N/A2025-03-07
00858965006809NATBLU119NA2023-07-13
00858965006878N/ATBL401N/A2024-10-08
00858965006885N/ATBL402N/A2024-10-08
20858965006889N/ATBL402N/A2024-10-08
00858965006915N/ATDLC211N/A2024-10-07
20858965006919N/ATDLC211N/A2024-10-07
00858965006748NATDLU213NA2023-05-26
00858965006861N/ATDLU205N/A2024-07-15
50858965006866N/ATDLU205N/A2024-07-15
00858965006854N/ATDLU232N/A2024-07-08
50858965006859N/ATDLU232N/A2024-07-08
00858965006847N/ATBL205N/A2024-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956487437CARDINAL HEALTHCardinal Health 200, LLCPWY2026-06-01
10198956487444CARDINAL HEALTHCardinal Health 200, LLCPWY2026-05-25
10198956402157CARDINAL HEALTHCardinal Health 200, LLCPWY2026-05-19
10198956421646CARDINAL HEALTHCardinal Health 200, LLCPWY2026-04-21
10198956429062CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-30
10198956419179CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-23
50198956419177CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-23
10198956233539CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-02
50198956233537CARDINAL HEALTHCardinal Health 200, LLCPWY2026-03-02
10198956369375CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-17
50198956369373CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-17
10198956357976CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-13
50198956357974CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-13
10198956353411CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-09
50198956353419CARDINAL HEALTHCardinal Health 200, LLCPWY2026-02-09
10198956336674CARDINAL HEALTHCardinal Health 200, LLCPWY2026-01-22
50198956336672CARDINAL HEALTHCardinal Health 200, LLCPWY2026-01-22
10198956267510CARDINAL HEALTHCardinal Health 200, LLCPWY2025-12-31
50198956267518CARDINAL HEALTHCardinal Health 200, LLCPWY2025-12-31
10198956259034CARDINAL HEALTHCardinal Health 200, LLCPWY2025-12-11
50198956259032CARDINAL HEALTHCardinal Health 200, LLCPWY2025-12-11
10198956220966CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-30
10198956208520CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-13
10198956215115CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-13
10198956197312CARDINAL HEALTHCardinal Health 200, LLCPWY2025-10-01
10198956095670CARDINAL HEALTHCardinal Health 200, LLCPWY2025-07-10
50198956095678CARDINAL HEALTHCardinal Health 200, LLCPWY2025-07-10
10198956073760CARDINAL HEALTHCardinal Health 200, LLCPWY2025-06-13
50198956073768CARDINAL HEALTHCardinal Health 200, LLCPWY2025-06-13
10198956082106CARDINAL HEALTHCardinal Health 200, LLCPWY2025-05-22