FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506083471
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST231288
Catalog number
ST231288
Device description
"PRISM CERVICAL CURETTE, 10"", STRAIGHT 3-0, TURQUOISE"
Published
2025-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCYCurette, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506083471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506083471001985060834711985060834710198506083471

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, reusableA collection of various surgical instruments, dressings, and materials intended to be used during obstetrical/gynaecological surgery. It is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific type of surgical procedure; it does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506044366ELMEDST52732404EST52732404E2026-06-09
00198506091278ELMED INCORPORATED55013-10A55013-10A2026-06-09
00198506091285ELMED INCORPORATED12-53785-042T12-53785-042T2026-06-09
00198506091292ELMED INCORPORATEDSS22-5200-09ASS22-5200-09A2026-06-09
00198506091308ELMED INCORPORATEDSS22-5200-09FSS22-5200-09F2026-06-09
00198506091315ELMED INCORPORATEDSTE379670STE3796702026-06-09
00198506091322ELMED INCORPORATEDSTE379675STE3796752026-06-09
00198506091339ELMED INCORPORATEDSTESM150526JC08ISTESM150526JC08I2026-06-09
00198506091346ELMED INCORPORATEDSTE4570910STE45709102026-06-09
00198506091353ELMED INCORPORATEDSTE239935STE2399352026-06-09
00198506091360ELMED INCORPORATED37350-64C137350-64C12026-06-09
00198506091377ELMED INCORPORATEDS37520-64C1S37520-64C12026-06-09
00198506091384ELMED INCORPORATED37520-06C137520-06C12026-06-09
00198506091391ELMED INCORPORATEDS37520-06C1S37520-06C12026-06-09
00198506091407ELMED INCORPORATEDSTE122857STE1228572026-06-09
00198506091476ELMED INCORPORATED12-36-1812-36-182026-06-09
00198506091483ELMED INCORPORATED51-4080-0851-4080-082026-06-09
00198506091490ELMED INCORPORATEDSTE321202EVSTE321202EV2026-06-09
00198506091568ELMED INCORPORATED115 515/715115 515/7152026-06-08
00842180148864ELMED INCORPORATED232 412232 4122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956475366CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-05
10198956366428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
10198956476530CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
07898506815111QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815135QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815159QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815319QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815333QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815340QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815357QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815364QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506840922QuinelatoSchobell Industrial LtdaHCY2023-01-09
10195594752279CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-26
10195594758813CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-25
10195594745776CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-18
10195594754730CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-15
10195594684549CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594758981CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594750367CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-12
10195594685485CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-08
10195594735142CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-07
10195594727260CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594727314CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594740702CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594745981CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594623807CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-24
10195594715830CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594717186CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594727680CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594730994CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23