FDA.reportPublic FDA data

AQUABLATION THERAPY®

Primary DI
00748426262076
Brand
AQUABLATION THERAPY®
Company
Microtek Medical LLC
Model
Patient Drapes
Catalog number
DR3900
Device description
Essential Drape Pack
Published
2026-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYYDrape, Urological, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYYDrape, Urological, DisposableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00748426262076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00748426262076007484262620767484262620760748426262076

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
106908437
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748426146802Medline-MicrotekFluid Warming - Warmer EquipmentEFW5L2026-05-20
00748426146925Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-1075EU2026-05-20
00748426146932Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-2038EU2026-05-20
00748426264483Medline-MicrotekPatient Drapes5960UK2026-03-16
00748426264490Medline-MicrotekEquipment Drapes8033651EU2026-03-16
00748426264506Medline-MicrotekEquipment Drapes49652026-03-16
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
00748426261543NA33206633202026-02-26
10748426261540NA33206633202026-02-26
10748426144294Medline-MicrotekEquipment Drapes5096NS2026-02-18
10748426144560Medline-MicrotekEquipment Drapes15427-002026-02-18
10748426144584Medline-MicrotekEquipment Drapes2904N2026-02-18
10748426144591Medline-MicrotekEquipment Drapes4604N2026-02-18
10748426144607Medline-MicrotekEquipment Drapes4650N2026-02-18
10748426144614Medline-MicrotekEquipment Drapes4954N2026-02-18
10748426144621Medline-MicrotekEquipment Drapes5900N2026-02-18
10748426144652Medline-MicrotekEquipment Drapes9604N2026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850055427099Essential Drape 1PKPROCEPT BioRobotics CorporationEYY2025-03-13
10850055427096Essential Drape 1PKPROCEPT BIOROBOTICS CORPORATIONEYY2025-03-13
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07333387044033GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
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07333387044125GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
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07333387044187GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
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07333387044309GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
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07333387044361GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387043951GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387044040GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387044200GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387044347GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIEYY2024-06-01
07333387043678SimPro™ SetWellspect ABEYY2024-05-02
07333387043739SimPro™ SetWellspect ABEYY2024-05-02
07333387043852SimPro™ SetWellspect ABEYY2024-05-02
07333387043494SimPro™ SetWellspect ABEYY2024-05-01
07333387043555SimPro™ SetWellspect ABEYY2024-05-01
07333387043616SimPro™ SetWellspect ABEYY2024-05-01
07333387043647SimPro™ SetWellspect ABEYY2024-05-01
07333387043623SimPro™ SetWellspect ABEYY2024-05-01