FDA.report

CARDINAL HEALTH

Primary DI
50197106948703
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-8210N
Catalog number
34-8210N
Device description
EPIDURAL TRAY
Published
2025-02-19
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

Related Records

Product Codes

CodeName
OGEEpidural anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106948703PackageGS120In Commercial Distribution
10197106948705PrimaryGS10

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956284980CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-24
50198956385854CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-23
50198956413748CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-23
50198956413908CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-23
50198956290837CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-16
50198956369823CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-10
50198956382464CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-10
50198956393590CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-09
50198956378375CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-03
50198956347623CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-02
50198956391107CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-02
50198956329704CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956338645CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956341010CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956341157CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956293906CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-13
50198956365597CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-13
50198956298024CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
50198956315981CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
50198956358056CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
04045928020866Design Options®B. BRAUN MEDICAL INC.OGE2026-02-03
04046955900534Perifix®B. BRAUN MEDICAL INC.OGE2026-02-03
04046955900855Design Options®B. BRAUN MEDICAL INC.OGE2026-02-03
50198956318340CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-26
50198956303902CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-23
50198956317152CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-22
50198956299144CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-15
00191072241689ACSAMERICAN CONTRACT SYSTEMS, INC.OGE2026-01-14
50198956180275CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-13
50198956316230CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-13