FDA.reportPublic FDA data

Turkel

Primary DI
10884521020634
Brand
Turkel
Company
Cardinal Health, Inc.
Model
8888568006
Catalog number
8888568006
Device description
Paracentesis Procedure Tray with Safety Components,8 Fr/Ch x 4-3/4 inch (2.7 mm x 12.1 cm) Catheter
Published
2016-09-24
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521020631PackageGS15Not in Commercial Distribution
10884521020634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102063120884521020631
1088452102063410884521020634

GMDN Terms#

Term, Definition table
TermDefinition
Aspiration tray, single-useA container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length4.75Inch

Storage And Handling#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541111HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541128HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541166HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541173HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541203HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541227HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541234HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541258HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541289HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541319HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541326HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541333HalyardAVID MEDICAL, INC.LRO2026-10-22
10885632541131SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-22
10809160540992HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160541012HALYARDAVID MEDICAL, INC.LRO2026-10-21
10809160541050Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRO2026-10-21
10809160541081HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160541098HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160541104HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160540862HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540886HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540916HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540923HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540930HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540947HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540954HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540961HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540978HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540985HalyardAVID MEDICAL, INC.LRO2026-10-20
00748426262069Medline-MicrotekMicrotek Medical LLCLRO2026-10-19