FDA.reportPublic FDA data

Curity

Primary DI
10884521020412
Brand
Curity
Company
Cardinal Health, Inc.
Model
97051
Catalog number
97051
Device description
Amniocentesis Tray
Published
2018-06-30
Public version status
Update
Distribution status
Not 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
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521020419PackageGS110Not in Commercial Distribution
10884521020412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102041920884521020419
1088452102041210884521020412

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, medicated, single-useA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521100401SharpSafety8602U8602U2016-09-24
10884527004676Argyle43309433092016-10-14
10884527005079Argyle43201432012016-09-24
10884527005086Argyle1604091604092016-09-24
10884527005147Argyle888816040888881604082016-09-24
10884527005215Argyle888816083888881608382016-09-24
10884527005222Argyle888816085388881608532016-09-24
20884527004680Argyle43311433112016-09-24
20884527020543Argyle888816044088881604402016-09-24
20884527020550Argyle888816045788881604572016-09-24
20884521012193Monoject888153576288815357622016-09-24
10884521022966Monoject8989PG28989PG22016-09-24
30884521019229SharpSafety882088202016-09-24
40884521022936Monoject8939PG28939PG22016-09-24
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144017596Metier MedicalMETIER MEDICAL LTDGAA2026-10-19
00860015723901NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723918NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723925NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723932NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
10198956491298CARDINAL HEALTHCardinal Health 200, LLCGAA2026-10-12
00817295020138InradInradGAA2026-10-09
00817295020145InradInradGAA2026-10-09
00817295020183InradInradGAA2026-10-09
00817295020190InradInradGAA2026-10-09
00817295020206InradInradGAA2026-10-09
00817295020213InradInradGAA2026-10-09
00817295020220InradInradGAA2026-10-09
00817295020237InradInradGAA2026-10-09
00817295020244InradInradGAA2026-10-09
00817295020251InradInradGAA2026-10-09
00817295020268InradInradGAA2026-10-09
00817295020275InradInradGAA2026-10-09
00817295020282InradInradGAA2026-10-09
00817295020299InradInradGAA2026-10-09
00817295020305InradInradGAA2026-10-09
00817295020312InradInradGAA2026-10-09
00817295020329InradInradGAA2026-10-09
00817295020336InradInradGAA2026-10-09
00817295020343InradInradGAA2026-10-09
00817295020350InradInradGAA2026-10-09
00817295020367InradInradGAA2026-10-09
00817295020374InradInradGAA2026-10-09
00817295020381InradInradGAA2026-10-09
00817295020398InradInradGAA2026-10-09