FDA.reportPublic FDA data

NA

Primary DI
20858965006544
Brand
NA
Company
PAJUNK MEDICAL SYSTEMS, LP
Model
TDLS204
Catalog number
NA
Device description
SINGLE SHOT NERVE BLOCK TRAY SonoPlex II Needle 22G x 2“ with Safersonic Probe Cover & Gel
Published
2020-06-15
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
20858965006544PackageGS110In Commercial Distribution
50858965006545PackageGS125In Commercial Distribution
00858965006540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085896500654420858965006544
5085896500654550858965006545
00858965006540008589650065408589650065400858965006540

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia catheter set, non-medicatedA collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-972-5865xx@xx.xx
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
false
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
00858965006946NATBL222NA2026-08-07
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956509498CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
10198956561878CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
B098AMS190500Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-08-21
04046955966370Design Options®B. BRAUN MEDICAL INC.OGJ2026-08-17
00849233018099Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-08-14
10198956516755CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956533219CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956429512CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956470545CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956523760CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956530447CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956533493CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
00628725050287Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
10198956530010CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-20
00628725050188Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050195Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050201Nerve Block TrayCHS USA Inc.OGJ2026-07-17
10198956500785CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
10198956524620CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
04046955966394Design Options®B. BRAUN MEDICAL INC.OGJ2026-06-25
00849233017948Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-06-23
10198956481176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-05
10198956458451CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-01
00849233014329Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-03-25
00628725050003Nerve Block TrayCHS USA Inc.OGJ2025-11-20
00628725050010Nerve Block TrayCHS USA Inc.OGJ2025-11-20
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