FDA UDI
In Commercial Distribution
🇺🇸 United States
SureStop
DI: 16940610100503
·
Model: 19x19mm
·
Huizhou Foryou Medical Devices Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
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Basic Information
- Brand Name
- SureStop
- Primary DI
- 16940610100503
- Version / Model
- 19x19mm
- Company Name
- Huizhou Foryou Medical Devices Co., Ltd.
- Labeler DUNS
- 529904325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-05-26
- Public Version
- 2
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 8e5ca814-b822-4f05-b7c0-9bcd7cabc17b
Device Description
SureStop Topical Hemostatic Dressing
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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58059 | Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial | A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26940610100500 | GS1 | Carton | 200 | In Commercial Distribution | |
| Primary | 16940610100503 | GS1 | ||||
| Unit of Use | 06940610100506 | GS1 |
Customer Contacts
- Phone
- +867525302185
- [email protected]