FDA.reportPublic FDA data

MEDLINE

Primary DI
06939029815170
Brand
MEDLINE
Company
Modern Medical Equipment MFG. Ltd.
Model
89056NS
Device description
Surgical irrigation/aspiration handpiece, single-use
Published
2017-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHFSystem, Evacuator, Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHFSystem, Evacuator, FluidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16939029815177PackageGS15In Commercial Distribution
26939029815174PackageGS14In Commercial Distribution
06939029815170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693902981517716939029815177
2693902981517426939029815174
06939029815170069390298151706939029815170

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration handpiece, single-useA hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
527812392
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939029817228OlympusWA98600A2018-04-11
06939029817235OlympusWA98700A2018-04-11
06939029815132OlympusET8652021-05-30
06939029817303OlympusPD650WA98225B2021-05-30
06939029817372OlympusPD735WA98216R2021-05-30
06939029817389OlympusPD635WA98215F2021-05-30
06939029817396OlympusPD635WA98225F2021-05-30
06939029817402OlympusPD635WA98216F2021-05-30
06939029817419OlympusPD635WA98226F2021-05-30
06939029817525OlympusMH432WA98400A2021-05-30
06939029818263OlympusET8652021-05-08
06939029818270OlympusET4562021-05-08
06939029818287OlympusET8652021-05-08
06939029818294OlympusEF4562021-05-08
06939029818317OlympusPD7352021-05-08
06939029818331OlympusPD6502021-05-08
06939029818355OlympusPD7352021-05-08
06939029818195OlympusEF4402021-05-07
06939029818201OlympusET8652021-05-07
06939029818218OlympusEF4412021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009877801ClearwandMORRIS MEDICAL, INC.FHF2024-10-22
00860009877818ClearwandMORRIS MEDICAL, INC.FHF2024-10-22
00607915146498Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
00607915146504Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
03700512902102RocaFlow Laparoscopy TubingPromeplaFHF2020-08-27
03700512912101RocaFlow Endoscopy TubingPromeplaFHF2020-08-27
03700512902034Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512902041Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512902058Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512902065Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512902072Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512902089Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512922032Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512922049Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512922056Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512922063Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512922070Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512922087Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512901976Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
03700512921974Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
06939029815187SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
26939029815181SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
06939029815163MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815167MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815174MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
03700512901839Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512901860Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512921837Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512921868Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512901815Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy - 1 spikePromeplaFHF2017-11-09