Identity
- Trade Name
- Lithotomy Drape FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 351101 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 351101 FDA UDI
- Primary DI / UDI-DI
- B6143511011 FDA UDI
- FDA Product Code
- EYY FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient surgical drape, single-use
Lithotomy Drape by PROCEPT BioRobotics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PROCEPT BioRobotics Corporation
Sources (1)
- FDA UDI 9120a126-3cda-4101-8b43-c52f611decae 34 fields · synced Jun 6, 2026