Identity
- Trade Name
- Essential Drape 1PK FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Model / Reference
- DR2500 FDA UDI
Identifiers
- Catalog Number
- DR2500 FDA UDI
- Primary DI / UDI-DI
- 00850055427099 FDA UDI
- FDA Product Code
- EYY FDA UDI
- GMDN Term
- Medical equipment/instrument 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
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Category: Patient surgical drape, single-useMedical equipment/instrument drape, single-use
Essential Drape 1PK 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 f7838e27-dab1-4837-8f1a-67bec6a0fe16 35 fields · synced Jun 1, 2026