ACE+ HAR36R
GUDID 10888551045117
Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 36cm
STERILMED, INC.
Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed| Primary Device ID | 10888551045117 |
| NIH Device Record Key | fbff6535-beb3-4682-9777-53c73f228ad1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE+ |
| Version Model Number | HAR36R |
| Catalog Number | HAR36R |
| Company DUNS | 175899459 |
| Company Name | STERILMED, 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)541-0078 |
| customerservice@sterilmed.com | |
| Phone | +1(888)541-0078 |
| customerservice@sterilmed.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com | |
| Phone | +1(888)541-0078 |
| sterilmedcs@its.jnj.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888551045117 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161086
FDA Product Code
| NUJ | ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
[10888551045117]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-17 |
On-Brand Devices [ACE+]
| 10888551045117 | Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 36cm |
| 10888551045100 | Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 23cm |
Trademark Results [ACE+]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACE+ 88056183 not registered Live/Pending |
Concentrated Active Ingredients & Flavors, Inc 2018-07-27 |
 ACE+ 88055864 5691624 Live/Registered |
Concentrated Active Ingredients & Flavors, Inc 2018-07-27 |
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