EndoSaph SAPHKITB06
GUDID 20884521051529
Vein Harvest System
Covidien LP
Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector Surgical balloon dissector| Primary Device ID | 20884521051529 |
| NIH Device Record Key | 172073e5-00c2-471d-a83a-a8297ae82947 |
| Commercial Distribution Discontinuation | 2019-10-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EndoSaph |
| Version Model Number | SAPHKITB06 |
| Catalog Number | SAPHKITB06 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
| Total Volume | 150 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521051522 [Primary] |
| GS1 | 20884521051529 [Package] Contains: 10884521051522 Package: CASE [6 Units] Discontinued: 2019-10-11 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K973046
FDA Product Code
| GCJ | Laparoscope, general & plastic surgery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by Covidien LP
| 10884521744134 - TruClear | 2024-04-23 Calibration Insert |
| 10884521744141 - TruClear | 2024-04-23 Calibration Insert |
| 10884521557048 - INVOS | 2024-04-22 Docking Station |
| 10884521833869 - Endoflip | 2024-04-22 Refurbished 300 Pump System With Pre-Use Tube |
| 20884521140216 - ClosureFast | 2024-04-15 Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m) |
| 10884521543430 - LiquiBand Exceed | 2024-04-15 2-Octyl Cyanoacrylate |
| 20884521140209 - ClosureFast | 2024-04-10 Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m) |
| 10884521539921 - VenaSeal | 2024-04-09 VenaSeal Closure System |
Trademark Results [EndoSaph]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSAPH 75210871 2201997 Live/Registered |
MALLINCKRODT ENTERPRISES HOLDINGS, INC. 1996-12-10 |
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