FDA UDI
In Commercial Distribution
🇺🇸 United States
PrecisionPass Lap Delivery Device
DI: 00801741031144
·
Model: 0118100
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PrecisionPass Lap Delivery Device
- Primary DI
- 00801741031144
- Version / Model
- 0118100
- Catalog Number
- 0118100
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4c3eecc9-eb1a-4998-a310-506b06abb2fb
Device Description
PrecisionPass Lap Delivery Device
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61372 | Surgical mesh laparoscopic delivery/positioning device | A sterile, hand-held manual surgical instrument intended to facilitate delivery and/or positioning of surgical mesh for implantation during laparoscopic surgery to repair an abdominal hernia/fascial defect. It consists of a handle with mechanical features used to deploy the mesh, and a distal section for mounting the mesh (e.g., collapsible frame or hollow tube) which is inserted through a laparoscopic port for positioning for subsequent fixation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741031141 | GS1 | CA | 5 | In Commercial Distribution | |
| Primary | 00801741031144 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 15 | Millimeter |