FDA.reportPublic FDA data

Inoculation Needles

Primary DI
28053326001103
Brand
Inoculation Needles
Company
COPAN ITALIA SPA
Model
176CSR40
Catalog number
176CSR40
Device description
STERILE NEEDLES IN RESEALABLE BAG OF 40 PIECES
Published
2024-01-17
Public version status
New
Distribution status
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
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38053326001100PackageGS14In Commercial Distribution
28053326001103PrimaryGS10
18053326001106Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3805332600110038053326001100
2805332600110328053326001103
1805332600110618053326001106

GMDN Terms#

Term, Definition table
TermDefinition
Inoculating tool IVD, manualA hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender handle with an attached loop or swab on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device.

Regulatory Flags#

DUNS number
428981112
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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58053326007021FLOQSwabs®53380CS0153380CS012026-03-20
38053326011826BD FCT4453884453882026-01-26
58053326011820BD FCT4453884453882026-01-26
38053326011598UTM®3C098N3C098N2024-11-13
38053326011604UTM® 3C099N01 3C099N01 2024-11-13
38053326011611UTM® 3C100N013C100N012024-11-13
38053326011796FLOQSwabs®5U200S01.BD5U200S01.BD2025-10-01
38053326008420UTM® 3C042N3C042N2022-12-13
38053326011772LBM CABroth4U161N4U161N2025-09-22
08053326011771LBM CABroth4U161N4U161N2025-09-22
58053326011653CLASSIQSwab10494425001104944250012025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® 10494417001104944170012025-07-03
38053326011710UriSponge™8U033S508U033S502025-03-12
38053326009557Copan Universal Transport Medium (UTM-RT) System3C047N3C047N2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) System3C057N3C057N2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) System3C064N3C064N2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) System3C075N3C075N2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) System3C085N013C085N012025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) System3C088N013C085N012025-05-28

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