FDA UDI
In Commercial Distribution
🇺🇸 United States
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH
DI: 00858736006007
·
Model: 7013-8410
·
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH
- Primary DI
- 00858736006007
- Version / Model
- 7013-8410
- Catalog Number
- 7013-8410
- Company Name
- HEMOSTATIX MEDICAL TECHNOLOGIES LLC
- Labeler DUNS
- 791221265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 92e7676c-9c9d-449a-9585-bf58205d948c
Device Description
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 36136 | Haemostatic knife | A hand-operated surgical instrument, similar in appearance to a surgical scalpel, designed for simultaneous cutting of tissues and cauterization (haemostasis) of blood vessels by applying an electrically-heated blade. It typically consists of a high-resistance, flat, sharp blade at the distal end and a handle at the proximal end with an electric cable; the blade is typically an integral part of the knife. Haemostasis is induced by direct transmission of thermal energy (heat) from the blade to the tissues; negating the use of grounding electrodes. It is used for a variety of procedures, including general and plastic surgery, gynaecology, and orthopaedics. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858736006007 | GS1 |
Customer Contacts
- Phone
- +1(901)262-0012
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091107 | 000 |