FDA UDI
In Commercial Distribution
🇺🇸 United States
LevaLap 1.0
DI: 00860006094201
·
Model: DMT-001
·
Core Access Surgical Technologies
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LevaLap 1.0
- Primary DI
- 00860006094201
- Version / Model
- DMT-001
- Company Name
- Core Access Surgical Technologies
- Labeler DUNS
- 118923670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-06
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- Update
- Public Device Record Key
- 3f35f5aa-2c72-456e-963a-d3a9b300e9bf
Device Description
Laparasopic access 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 |
|---|---|---|---|---|
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | 884.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61851 | Laparoscopic access suction dome | A sterile dome-shaped device intended to facilitate laparoscopic-insufflation needle insertion by causing the anterior abdominal wall to separate from the underlying viscera using vacuum applied to the surface of the abdomen, thereby creating a space for the needle tip. It is typically made of synthetic polymer materials and is designed to be used with the hospital central vacuum system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006094201 | GS1 | ||||
| Package | 10860006094208 | GS1 | Case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212786 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 50 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry; keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 50 Degrees Celsius