FDA.reportPublic FDA data

Essential Drape 1PK

Primary DI
00850055427099
Brand
Essential Drape 1PK
Company
PROCEPT BioRobotics Corporation
Model
DR2500
Catalog number
DR2500
Published
2025-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
10850055427096PackageGS15In Commercial Distribution
00850055427099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005542709610850055427096
00850055427099008500554270998500554270990850055427099

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(650)232-7223customerservice@procept-biorobotics.com

Regulatory Flags#

DUNS number
016646472
Device count
1
Premarket exempt
true
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
00850055427051HYDROS HandpieceHH10002024-09-06
00850055427068HYDROS Robotic SystemHY10002024-09-06
00850055427075HYDROS TRUS ProbeHU10002024-09-06
00850055427037AquaBeam HandpieceHP2000HP2000-C2023-12-15
00850055427006AquaBeam HandpieceHP2000HP2000-D2023-08-25
00850055427013AquaBeam ScopeSC2000SC2000-D2023-08-25
00850055427020AquaBeam Robotic SystemAB2000AB2000-D, AB2000-E2023-08-25
00850055427129AquaBeam HandpieceHP2000HP2000-E2026-04-28
B614AB20001AquaBeam Robotic SystemAB2000AB20002019-03-28
B614HP2000X1AquaBeam HandpieceHP2000HP20002022-05-31
B614SC20001AquaBeam ScopeSC2000SC2000-A2019-03-28
00860009122932Lithotomy DrapeFG351101FG3511012023-04-05
00850055427044Lithotomy DrapeFG3511013511012023-12-15
B614HP20001AquaBeam HandpieceHP2000HP20002019-03-28
B614AB2000C1AquaBeam Robotic SystemAB2000CAB20002021-04-06
B6142101011AquaBeam System2101012101012018-01-11
B6142105011AquaBeam Scope2105012105012018-01-11
B6143103011AquaBeam Handpiece3103012018-01-11
B6143511011Lithotomy Drape3511013511012017-12-06
10850055427096Essential Drape 1PKDR2500DR25002025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426262076AQUABLATION THERAPY®Microtek Medical LLCEYY2026-04-06
10850055427096Essential Drape 1PKPROCEPT BIOROBOTICS CORPORATIONEYY2025-03-13
07333387043913GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387043944GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387043975GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044002GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044033GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044064GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044095GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044125GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044156GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044187GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044217GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044248GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044279GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044309GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
07333387044330GentleCath Hydrophilic KitWellspect ABEYY2024-06-01
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