FDA UDI
In Commercial Distribution
🇺🇸 United States
Lithotomy Drape
DI: 00860009122932
·
Model: FG351101
·
PROCEPT BIOROBOTICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Lithotomy Drape
- Primary DI
- 00860009122932
- Version / Model
- FG351101
- Catalog Number
- FG351101
- Company Name
- PROCEPT BIOROBOTICS CORPORATION
- Labeler DUNS
- 016646472
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-05
- Public Version
- 1
- Public Version Date
- 2023-04-13
- Public Version Status
- New
- Public Device Record Key
- cf470c15-abb7-44ba-b91a-74adaabd7755
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EYY | Drape, urological, disposable | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47783 | Patient surgical drape, single-use | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860009122939 | GS1 | Shipper Box | 8 | In Commercial Distribution | |
| Primary | 00860009122932 | GS1 | ||||
| Previous | B6143511011 | HIBCC |
Customer Contacts
- Phone
- +1(650)232-7222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius