FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885425487026
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SSI-0029
Catalog number
SSI-0029
Device description
STERILE GRAVES VAG. SPECULUM
Published
2019-05-28
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
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425487026PackageGS120In Commercial Distribution
10885425487028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542548702650885425487026
1088542548702810885425487028

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery 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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776428150MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428181MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428198MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428242MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776419622MillenniumAvalign Technologies, Inc.HDF2026-08-23
B382SD915039080Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039140Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039150Surgical DirectSurgical Direct, Inc.HDF2026-08-21
00190776426439MillenniumAvalign Technologies, Inc.HDF2026-08-18
00190776426446MillenniumAvalign Technologies, Inc.HDF2026-08-18
00198506093944ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094088ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094095ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094101ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094118ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00850088713534PRINCETONPrinceton Medical Group, Inc.HDF2026-08-14
00190776408817MillenniumAvalign Technologies, Inc.HDF2026-08-03
00190776422639MillenniumAvalign Technologies, Inc.HDF2026-08-03
00198506093845ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-29
00198506093852ELMEDELMED INCORPORATEDHDF2026-07-29
00198506093142ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093265ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093272ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093418ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
B382SD915038100Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038120Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915039110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471000Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471130Surgical DirectSurgical Direct, Inc.HDF2026-07-28