LevaLap 1.0
GUDID 00860006094201
Laparasopic access device
Core Access Surgical Technologies
Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome Laparoscopic access suction dome| Primary Device ID | 00860006094201 |
| NIH Device Record Key | 3f35f5aa-2c72-456e-963a-d3a9b300e9bf |
| Brand Name | LevaLap 1.0 |
| Version Model Number | DMT-001 |
| Company DUNS | 118923670 |
| Company Name | Core Access Surgical Technologies |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860006094201 [Primary] |
| GS1 | 10860006094208 [Package] Package: Case [10 Units] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212786
FDA Product Code
| HIF | Insufflator, Laparoscopic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Device Record Status | Published |
| Public Version Number | 0 |
| Device Publish Date | 2023-03-06 |
Trademark Results [LevaLap 1.0]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEVALAP 1.0 97056921 not registered Live/Pending |
Core Access Surgical Technologies, Inc. 2021-10-01 |
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