FDA.report

CARDINAL HEALTH

Primary DI
50197106936113
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA45TLS13
Catalog number
SMA45TLS13
Device description
TLH PACK
Published
2025-02-11
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
OHDGynecological laparoscopic kit

Product Code Classifications

CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106936113PackageGS12In Commercial Distribution
10197106936115PrimaryGS10

GMDN Terms

TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical procedure. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
50198956314687CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956374148CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956382433CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956399301CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956418194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425611CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956258257CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956343243CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956350708CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956353273CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956370270CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956386868CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956389487CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956392401CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956416909CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956419979CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956420555CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956420920CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956431988CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956218763CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956218824CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956259704CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956325362CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956327137CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956334029CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956341607CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956350869CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956364958CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956383010CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19