FDA UDI
In Commercial Distribution
🇺🇸 United States
Delasco ADAPT/6 Needle Adapter
DI: 00609960000305
·
Model: ADAPT/6
·
DERMATOLOGIC LAB AND SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Delasco ADAPT/6 Needle Adapter
- Primary DI
- 00609960000305
- Version / Model
- ADAPT/6
- Catalog Number
- ADAPT/6
- Company Name
- DERMATOLOGIC LAB AND SUPPLY, INC.
- Labeler DUNS
- 021628771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-15
- Public Version
- 3
- Public Version Date
- 2018-08-29
- Public Version Status
- Update
- Public Device Record Key
- 56e5af0c-61af-473f-a07b-ef6087d5706b
Device Description
These needle adapters allow you to attach a metal hub needle to any electrosurgical unit. The adapters have a 3/32" (2.4mm) diameter shaft size, which fits most electrosurgical units. ADAPT/6 has a shaft (1 3/8") which was designed specifically for the Delasco 734/1134 and Aaron/Bovie handpieces. This will fit most other electrosurgical units as well but may stick out of the handpiece slightly longer. Luer lock connection, reusable and convenient. Accepts metal hub, Luer Lock needles. This device is subject to direct marking, but excepted due to technological infeasibility.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 61876 | Open-surgery electrosurgical electrode, monopolar, reusable | An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00609960000305 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001029 | 000 |