FDA.reportPublic FDA data

Lithotomy Drape

Primary DI
B6143511011
Brand
Lithotomy Drape
Company
PROCEPT BioRobotics Corporation
Model
351101
Catalog number
351101
Device description
The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
Published
2017-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
B6143511012PackageHIBCC8In Commercial Distribution
B6143511018PackageHIBCC8Not in Commercial Distribution
B6143511011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016646472
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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
00850055427099Essential Drape 1PKPROCEPT BioRobotics CorporationEYY2025-03-13
10850055427096Essential Drape 1PKPROCEPT BIOROBOTICS CORPORATIONEYY2025-03-13
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