FDA.reportPublic FDA data

NA

Primary DI
50858965006927
Brand
NA
Company
PAJUNK MEDICAL SYSTEMS, LP
Model
TDLS217
Catalog number
NA
Device description
CUSTOM SINGLE SHOT NERVE BLOCK TRAY (SonoPlex II Needle 20Gx100mm with CIVCO Probe Cover & Gel)
Published
2025-07-07
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
OGJNerve Block Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50858965006927PackageGS125In Commercial Distribution
00858965006922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085896500692750858965006927
00858965006922008589650069228589650069220858965006922

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia single-administration set, medicatedA collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. 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
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
20858965006872N/ATBL401N/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
10198956481176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-05
10198956458451CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-01
10195327297756Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-13
10193489212969Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215441Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215885Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489217667Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489415827Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489422481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489426816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489428780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432077Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489445497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489447156Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489454994Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489810479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
H65857032375Henry ScheinHENRY SCHEIN, INC.OGJ2022-12-13
10195327243142Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-11-24
H65857032195Henry ScheinHENRY SCHEIN, INC.OGJ2022-10-25
10193489848304Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-09-04
10193489415780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-08-04
10193489417999Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-08-04
10193489432091Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-07-03
10193489403879Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-24
10193489216110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-17
10193489452754Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-17
10193489457605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-10
10195327022815Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-01
10195594502546CARDINAL HEALTHCardinal Health 200, LLCOGJ2022-02-26