EndoWrist SP
GUDID 00886874114308
NEEDLE DRIVER
INTUITIVE SURGICAL, INC.
Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable| Primary Device ID | 00886874114308 |
| NIH Device Record Key | 8948c68b-d34b-438a-973f-939c281ab239 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoWrist SP |
| Version Model Number | 430006 |
| Company DUNS | 938647021 |
| Company Name | INTUITIVE SURGICAL, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
| Outer Diameter | 6 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886874114308 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173906
FDA Product Code
| NAY | System, surgical, computer controlled instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
[00886874114308]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2018-09-20 |
On-Brand Devices [EndoWrist SP]
| 00886874115213 | CADIERE FORCEPS |
| 00886874115190 | ROUND TOOTH RETRACTOR |
| 00886874114384 | CAMERA, 0° |
| 00886874114339 | FENESTRATED BIPOLAR FORCEPS |
| 00886874114322 | MARYLAND BIPOLAR FORCEPS |
| 00886874114315 | MONOPOLAR CAUTERY INSTRUMENT |
| 00886874114308 | NEEDLE DRIVER |
| 00886874114292 | MEDIUM-LARGE CLIP APPLIER |
| 00886874114285 | MONOPOLAR CURVED SCISSORS |
| 00886874122228 | CAMERA, 0° |
Trademark Results [EndoWrist SP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOWRIST SP 87198489 5944462 Live/Registered |
INTUITIVE SURGICAL OPERATIONS, INC. 2016-10-10 |
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