FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE+
DI: 10888551045100
·
Model: HAR23R
·
STERILMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACE+
- Primary DI
- 10888551045100
- Version / Model
- HAR23R
- Catalog Number
- HAR23R
- Company Name
- STERILMED, INC.
- Labeler DUNS
- 175899459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-17
- Public Version
- 4
- Public Version Date
- 2019-08-14
- Public Version Status
- Update
- Public Device Record Key
- 8b0b6c11-bd53-41d6-9489-7705e35860de
Device Description
Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 23cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUJ | ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61817 | Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed | A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888551045100 | GS1 |
Customer Contacts
- Phone
- +1(888)541-0078
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161086 | 000 |