FDA.reportPublic FDA data

Turkel

Primary DI
20884521020624
Brand
Turkel
Company
Cardinal Health, Inc.
Model
8888567032
Catalog number
8888567032
Device description
Pneumothorax Procedure Tray with Safety Components,8 Fr/Ch x 3-1/2 inch (2.7 mm x 8.9 cm) Catheter
Published
2016-09-24
Public version status
Update
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
LROGeneral surgery tray

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934428000ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAYSherwood Medical Co.1993-12-30LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521020624PackageGS15In Commercial Distribution
10884521020627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102062420884521020624
1088452102062710884521020627

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
Length3.5Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521148342Kendall22660A22660A2017-08-02
20884521148397Kendall31244422A31244422A2016-09-24
10884521007086Monoject118881811311888181132016-09-24
10884521007109Monoject118881910011888191002016-09-24
10884521007116Monoject118881911211888191122016-09-24
10884521007130Monoject118882011211888201122016-09-24
30884521024841Kendall923692362018-06-30
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS192900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-19
10809160527177HALYARDAVID MEDICAL, INC.LRO2026-07-17
10809160527313HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527320HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527344HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527351HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527368HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527399HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527405HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527412HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527443HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527450HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527467HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527474HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527481HalyardAVID MEDICAL, INC.LRO2026-07-17
10198956344020CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956418431CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956439887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956444386CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956462175CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956472105CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477391CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956479845CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956483439CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956488304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956502437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956504868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956508149CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16