FDA.reportPublic FDA data

Essential Drape 1PK

Primary DI
10850055427096
Brand
Essential Drape 1PK
Company
PROCEPT BIOROBOTICS CORPORATION
Model
DR2500
Catalog number
DR2500
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
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
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00850055427099Essential Drape 1PKDR2500DR25002025-03-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426262076AQUABLATION THERAPY®Microtek Medical LLCEYY2026-04-06
00850055427099Essential Drape 1PKPROCEPT BioRobotics CorporationEYY2025-03-13
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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