LevaLap 1.0
GUDID 00860006094201
Laparasopic access device
Core Access Surgical Technologies
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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