FDA UDI
In Commercial Distribution
🇺🇸 United States
FS Dispenser, Stainless
DI: 00370275092025
·
Model: Stainless FS Dispenser 1ct
·
Forward Science Technologies LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FS Dispenser, Stainless
- Primary DI
- 00370275092025
- Version / Model
- Stainless FS Dispenser 1ct
- Company Name
- Forward Science Technologies LLC
- Labeler DUNS
- 079212068
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-14
- Public Version
- 1
- Public Version Date
- 2024-10-22
- Public Version Status
- New
- Public Device Record Key
- ab2cf3e9-fcdc-4e5c-8624-61835c3c61bc
Device Description
The Stainless FS Dispenser is a hand-held syringe-like device that has a ring-handled plunger, a barrel with finger grips, and a mechanism for holding an insertable cartridge containing PerioStom. The Stainless FS Dispenser is a reusable and autoclavable device made of stainless steel that will primarily be used in clinical or healthcare facility settings where patients are receiving services. It will be provided non-sterile but is intended to be sterilized before use.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCP | Syringe, Ent | Ear, Nose, Throat | 874.5220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47439 | Periodontal medication dispenser | A hand-held manual dental instrument intended to deliver medication (e.g., an antibiotic) directly into a periodontal pocket for the treatment of chronic periodontitis. It is typically a syringe-like device that has a ring-handled plunger, a barrel with finger grips, and a mechanism for holding an insertable cartridge containing the medication. It is usually made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00370275092025 | GS1 |