FDA.reportPublic FDA data

TLS

Primary DI
37613252088470
Brand
TLS
Company
Stryker Leibinger GmbH & Co. KG
Model
6650
Catalog number
6650
Device description
10 French Drain System, Sterile
Published
2016-08-24
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
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833586000TLS BULB DRAINAGE SYSTEMPorex Medical1984-01-30GCY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613252088470PrimaryGS10
07613252088479Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761325208847037613252088470
07613252088479076132520884797613252088479

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainage kitA collection of sterile devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
6
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37613327122962NA29-9300329-930032018-04-13
04546540274250NA64-0013264-001322017-01-11
07613327122893NA29-9300129-930012017-12-01
07613327122909NA29-9200129-920012017-03-31
07613327122916NA29-9200329-920032017-03-31
07613327122930NA29-9200229-920022017-03-31
07613327122947NA29-9100229-910022017-03-31
07613327122978NA29-9300229-930022017-12-01
07613327123326NA29-9200429-920042017-03-31
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956231788CARDINAL HEALTHCardinal Health 200, LLCGCY2025-10-20
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
50192253042748ArgyleCardinal Health 200, LLCGCY2025-10-02
50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
00630094061504Bioseal Inc.BIOSEALGCY2024-01-29
00630094061511Bioseal Inc.BIOSEALGCY2024-01-29
00630094061528Bioseal Inc.BIOSEALGCY2024-01-29
00630094049175Bioseal Inc.BIOSEALGCY2024-01-25
10197106520932CARDINAL HEALTHCardinal Health 200, LLCGCY2024-01-24
00630094049052Bioseal Inc.BIOSEALGCY2024-01-24
00630094049168Bioseal Inc.BIOSEALGCY2024-01-24
00630094043807Bioseal Inc.BIOSEALGCY2024-01-19
00630094043814Bioseal Inc.BIOSEALGCY2024-01-19
00630094192222Bioseal Inc.BIOSEALGCY2023-12-07
00630094196800Bioseal Inc.BIOSEALGCY2023-11-29
00630094196817Bioseal Inc.BIOSEALGCY2023-11-29
00630094196824Bioseal Inc.BIOSEALGCY2023-11-29
00630094196831Bioseal Inc.BIOSEALGCY2023-11-29
00630094196855Bioseal Inc.BIOSEALGCY2023-11-29
00630094196862Bioseal Inc.BIOSEALGCY2023-11-29
00630094196879Bioseal Inc.BIOSEALGCY2023-11-29
00630094196909Bioseal Inc.BIOSEALGCY2023-11-29
00630094196916Bioseal Inc.BIOSEALGCY2023-11-29
00630094196954Bioseal Inc.BIOSEALGCY2023-11-29
00630094196961Bioseal Inc.BIOSEALGCY2023-11-29
00630094196985Bioseal Inc.BIOSEALGCY2023-11-29
00630094197005Bioseal Inc.BIOSEALGCY2023-11-29