FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Seal
DI: 00017276240160
·
Model: 017276240160
·
Aso LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Rapid Seal
- Primary DI
- 00017276240160
- Version / Model
- 017276240160
- Company Name
- Aso LLC
- Labeler DUNS
- 152793493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-30
- Public Version
- 1
- Public Version Date
- 2024-12-09
- Public Version Status
- New
- Public Device Record Key
- 9ddbc15d-48b7-4d4e-8cc2-0f6183a75739
Device Description
Antibacterial, Rapid Seal Wound Gel, 8 uses, 0.3 FL OZ (8 ml)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65341 | Chitosan haemostatic agent, home-use | 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 by a layperson at home to superficial wounds (e.g., minor cuts, lacerations, abrasions) to produce a rapid haemostasis by forming a robust plug of gel which is removed after use; it is not intended for severe wounds/emergency situations. 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 |
|---|---|---|---|---|---|---|
| Package | 20017276240164 | GS1 | 36 | In Commercial Distribution | ||
| Primary | 00017276240160 | GS1 |
Customer Contacts
- Phone
- 18558234545
- [email protected]