FDA UDI
In Commercial Distribution
🇺🇸 United States
Delasco Electrosurgical Handpiece Sheath
DI: 10609960001255
·
Model: 26150
·
DERMATOLOGIC LAB AND SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Delasco Electrosurgical Handpiece Sheath
- Primary DI
- 10609960001255
- Version / Model
- 26150
- Company Name
- DERMATOLOGIC LAB AND SUPPLY, INC.
- Labeler DUNS
- 021628771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-07-10
- Public Version
- 1
- Public Version Date
- 2018-08-10
- Public Version Status
- New
- Public Device Record Key
- ad53d74b-9f4a-43ef-88dd-e7971b450b8b
Device Description
SHEATHS, ELECTROSURGICAL, 26100 SAMPLE PK5. A non-sterile sheath designed to fit over most electrosurgical handpieces. Latex-free, 8" long with 7/8" diameter opening. Sample pack of 5. Medical device.
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
- 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
- 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 |
|---|---|---|---|---|
| 61049 | Instrument/equipment drape, single-use, non-sterile | A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10609960001255 | GS1 | ||||
| Unit of Use | 00609960000275 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992149 | 000 |