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
04546540256805NA62-0053462-005342016-10-19
04546540356529NA60-1605060-160502016-08-24
04546540356628NA62-0030262-003022016-12-08
07613154185443NA62-0044162-004412016-12-08
07613252313069DELTA70-9200970-920092015-09-24
07613252444220DELTA70-9200670-920062015-09-24
07613252444244DELTA70-9200370-920032015-09-24
07613327090123NA62-2014962-201492016-10-19
07613327090192NA62-2013962-201392016-10-19
07613327123340Delta70-9205670-920562015-09-24
07613327123364Delta70-9205570-920552015-09-24
04546540366788NA62-2052062-205202016-10-19
04546540391391NA62-0020862-002082016-12-08
07613154731800NA92-1592392-159232017-01-11
07613154732685NA92-1592192-159212017-01-11
07613252727002DELTA70-9204770-920472015-09-24
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060206036haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206043haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206050haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206067haakaaTHINK GREEN LIMITEDGCY2026-09-20
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
00848530106973Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106980Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106997Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107000Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107017Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106966Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107185Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-12
00848530106164Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106171Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106188Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530095222Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106201Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106218Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106225Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106232Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106256Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106263Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106270Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530104467Suction KitSunset Healthcare Solutions, Inc.GCY2025-04-14