FDA.reportPublic FDA data

Argyle

Primary DI
20884521050799
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888561068
Catalog number
8888561068
Device description
Trocar Catheter,Sharp Tip
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521050799PackageGS110In Commercial Distribution
10884521050792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452105079920884521050799
1088452105079210884521050792

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge28French
Length15.75Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867500914Arthrex®ARTHREX, INC.DRC2026-03-13
04262494463594N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463631N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463785N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463792N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463808N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463815N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463822N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463839N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463846N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494461064N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461224N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461019N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461026N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461033N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461040N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461057N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461071N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461088N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461095N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461101N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461118N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461125N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461132N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461149N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461156N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461163N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461170N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461187N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461194N/ADoppkon GmbH & Co. KGDRC2025-08-04