FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594953522
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-4725E
Catalog number
34-4725E
Device description
PAIN TRAY
Published
2021-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594953520PackageGS120In Commercial Distribution
10195594953522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559495352050195594953520
1019559495352210195594953522

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956435728CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956524613CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956518650CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-16
10198956437500CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-09
10198956202320CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956381124CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956520196CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956381070CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-23
10198956486232CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-05
10198956454705CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-03
10198956405004CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-01
H65857032365Henry ScheinHENRY SCHEIN, INC.OFQ2022-12-12
H65857032105Henry ScheinHENRY SCHEIN, INC.OFQ2022-10-25
H65857032025Henry ScheinHENRY SCHEIN, INC.OFQ2022-09-19
10195594520434CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-09-02
10195594516130CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-07-21
10195594419592CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-05-09
H65857030615Henry ScheinHENRY SCHEIN, INC.OFQ2022-04-29
10195594375423CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594516338CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594509859CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-14
10195594450717CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-10
10195594501136CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519902CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519919CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594492106CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-01
10195594476199CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-26
10195594456221CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-15
10195594487225CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-11
10195594500009CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10