FDA UDI
In Commercial Distribution
🇺🇸 United States
HEMOSTATIX THERMAL SCALPEL SYSTEM HANDLE
DI: 00858736006113
·
Model: 7023-5815
·
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- HEMOSTATIX THERMAL SCALPEL SYSTEM HANDLE
- Primary DI
- 00858736006113
- Version / Model
- 7023-5815
- Catalog Number
- 7023-5815
- Company Name
- HEMOSTATIX MEDICAL TECHNOLOGIES LLC
- Labeler DUNS
- 791221265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-04-11
- Public Version
- 1
- Public Version Date
- 2019-04-19
- Public Version Status
- New
- Public Device Record Key
- b5a98c36-12ca-4612-a7aa-a0cc6b75e5f5
Device Description
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5815 BLADE
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
- 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 |
|---|---|---|---|---|
| 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 | 00858736006113 | GS1 | ||||
| Unit of Use | 00858736006205 | GS1 |
Customer Contacts
- Phone
- +1(901)261-0012
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183009 | 000 |