FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambler Surgical
DI: 10190660000889
·
Model: PD7213
·
AMBLER SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ambler Surgical
- Primary DI
- 10190660000889
- Version / Model
- PD7213
- Catalog Number
- PD7213
- Company Name
- AMBLER SURGICAL CORP.
- Labeler DUNS
- 015272206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 41be11aa-5074-44da-a763-8e6194918111
Device Description
Bipolar pencil, 18 gauge wide stroke, non-stick, angled 30º tip, sterile, disposable, box of 10
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56296 | Open-surgery electrosurgical handpiece/electrode, bipolar, single-use | A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00190660000882 | GS1 | BX | 10 | In Commercial Distribution | |
| Primary | 10190660000889 | GS1 |
Customer Contacts
- Phone
- +1(888)407-0006 ext. 0
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K864402 | 000 |