FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594044570
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA29VGMH5
Catalog number
SMA29VGMH5
Device description
PERI GYN PACK
Published
2021-04-23
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

Product Codes#

Code, Name table
CodeName
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594044570PackageGS12In Commercial Distribution
10195594044572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559404457050195594044570
1019559404457210195594044572

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS197460Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-18
B098AMS8132B0Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-18
10198956359291CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956464520CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956468481CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956497757CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956524378CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956558182CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956561441CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956570641CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956570658CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956571693CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956494053CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956546554CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956547599CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956550315CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956552579CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956561410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956563551CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956565289CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956520851CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-18
10198956406964CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956427020CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956498419CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956505780CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956508828CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956520493CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956547841CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10809160528334HALYARDAVID MEDICAL, INC.OHD2026-08-01
10198956368125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31