FDA UDI
In Commercial Distribution
🇺🇸 United States
Ax-Surgi Surgical Hemostat
DI: 00860012016648
·
Model: SH1006
·
Advamedica Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ax-Surgi Surgical Hemostat
- Primary DI
- 00860012016648
- Version / Model
- SH1006
- Company Name
- Advamedica Inc.
- Labeler DUNS
- 118526617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-28
- Public Version
- 2
- Public Version Date
- 2025-01-20
- Public Version Status
- Update
- Public Device Record Key
- abf2cd29-af50-40e3-af26-d604d58cfcae
Device Description
Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It is intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
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
- 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 |
|---|---|---|---|---|
| POD | Temporary, Internal Use Hemostatic | General, Plastic Surgery | 878.4454 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46922 | Chitosan haemostatic agent, professional, non-bioabsorbable | A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012016648 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213198 | 000 |