EndoSaph SAPHKITB06
GUDID 20884521051529
Vein Harvest System
Covidien LP
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
| 10884521851566 - Valleylab | 2025-05-20 FT10 Electrosurgical Generator |
| 20884521850115 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 3 |
| 20884521850122 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 4 |
| 20884521850139 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 2 |
| 30884521850143 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 1 |
| 10884521851559 - Vital Sync | 2025-05-05 VITAL SYNC Mobile V4 SOFTWARE |
| 20884521084992 - DAR | 2025-04-21 Catheter Mount |
| 20884521842530 - DAR | 2025-04-21 Catheter Mount Extension Tube |
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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