Harmonic HAR1120
GUDID 20705036026171
HARMONIC 1100 Shears, 20cm Shaft Length
ETHICON ENDO-SURGERY, LLC
Soft-tissue ultrasonic surgical system handpiece tip, single-use| Primary Device ID | 20705036026171 |
| NIH Device Record Key | 46b5d711-a095-454f-9dda-63401a9fe867 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Harmonic |
| Version Model Number | HAR1120 |
| Catalog Number | HAR1120 |
| Company DUNS | 044606982 |
| Company Name | ETHICON ENDO-SURGERY, LLC |
| 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
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705036026174 [Primary] |
| GS1 | 20705036026171 [Package] Contains: 10705036026174 Package: BOX [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200841
FDA Product Code
| LFL | Instrument, ultrasonic surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2020-12-11 |
On-Brand Devices [Harmonic]
| 20705036015052 | HARMONIC HD 1000i Shears, 36cm Shaft Length |
| 20705036015045 | HARMONIC HD 1000i Shears, 20cm Shaft Length |
| 30705036014731 | HS FOCUS 17 CM PLUS ADAPTIVE |
| 10705036013990 | Harmonic Generator Connector |
| 10705036012627 | Harmonic Sterilization Tray |
| 30705036011938 | Harmonic Disposable Hand Switching Adaptors |
| 10705036003274 | Harmonic Blue Test Tip for use with Blue Hand Piece Only |
| 30705036003117 | Harmonic Torque Lock Blade Wrench |
| 10705036002192 | Harmonic Test Tip |
| 30705036002172 | Harmonic 5mm Adaptor |
| 10705036002154 | Harmonic Blue Hand Piece and Blue Test Point |
| 10705036002147 | Harmonic Hand Piece |
| 30705036002127 | Harmonic Combination Hook Blades 10mm |
| 30705036002097 | Harmonic Curved Blades 5mm |
| 30705036001632 | Harmonic Dissecting Hooks with Protective Sleeves-10cm |
| 10705036015055 | HARMONIC HD 1000i Shears, 36cm Shaft Length |
| 10705036015048 | HARMONIC HD 1000i Shears, 20cm Shaft Length |
| 20705036026171 | HARMONIC 1100 Shears, 20cm Shaft Length |
| 20705036026164 | HARMONIC 1100 Shears, 36cm Shaft Length |
| 30705036023443 | HARMONIC BLUE HAND PIECE |
| 30705036023429 | HARMONIC GREY HAND PIECE |
| 20705036015489 | ENSEAL X1 STRAIGHT 37CM SHAFT |
| 20705036015458 | ENSEAL X1 STRAIGHT 25CM SHAFT |
| 20705036035784 | Harmonic 700 Shears, Advanced Hemostasis |
| 20705036035777 | Harmonic 700 Shears, Advanced Hemostasis |
| 20705036035760 | Harmonic 700 Shears, Advanced Hemostasis |
Trademark Results [Harmonic]
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