FDA.reportPublic FDA data

LF

Primary DI
20746190002397
Brand
LF
Company
LIEBEL-FLARSHEIM COMPANY LLC
Model
335825
Device description
Drain Bag - use with Hydra Vision or Direct Digital Urology Systems
Published
2020-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KQSTable, Cystometric, Non-Electric And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQSTable, Cystometric, Non-Electric And AccessoriesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20746190002397PackageGS110In Commercial Distribution
10746190002390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2074619000239720746190002397
1074619000239010746190002390

GMDN Terms#

Term, Definition table
TermDefinition
Urological operating table, electrohydraulicA mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. Commonly known as a transurethral resection (TUR) table, its surface consists of a flat section with a headrest; it includes adjustable leg holders/stirrups either directly attached to the table or to its side rails. It may also include traction handles and an integrated urine/irrigation fluid collection tray with a filter to catch urinary stones and/or stone fragments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152760567
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10746190002222LF8105512018-12-07
10746190002260LF8440122016-09-09
10746190002116LF8000992016-09-09
10746190002376LF9001052016-09-09
10746190002208LF8018002016-09-09
10746190002314LF8440222016-09-09
10746190002109LF8000962016-09-09
10746190002307LF8440212016-09-09
10746190002321LF8440232016-09-09
10746190002000LF3020502016-09-16
10746190005049LF9898 012 200462024-12-30
10746190002239LF8105552018-12-07
10746190002024LF6002692016-09-09
10746190002048LF6011952016-09-09
10746190002086LF6012802020-03-03
10746190002185LF8011062016-09-09
10746190002192LF8011072016-09-09
10746190002215LF8018012016-09-09
10746190002246LF8440102016-09-09
10746190002253LF8440112016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10746190004516LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004523LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004530LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004547LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004554LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004608LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004615LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004639LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004660LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190004684LFLiebel-Flarsheim Company LLCKQS2021-12-31
10746190002383LFLiebel-Flarsheim Company LLCKQS2020-09-10
10746190002390LFLiebel-Flarsheim Company LLCKQS2020-09-10
20746190002380LFLIEBEL-FLARSHEIM COMPANY LLCKQS2020-09-10
04049957000714Dornier MedTechDornier MedTech GmbHKQS2018-09-13