FDA UDI
In Commercial Distribution
🇺🇸 United States
PlastCare
DI: D066PGS3CC27GKIT1
·
Model: PG-S3CC27G KIT
·
Proguard Health, Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- PlastCare
- Primary DI
- D066PGS3CC27GKIT1
- Version / Model
- PG-S3CC27G KIT
- Catalog Number
- PG-S3CC27G KIT
- Company Name
- Proguard Health, Inc
- Labeler DUNS
- 129529337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-07-02
- Public Version
- 1
- Public Version Date
- 2021-07-12
- Public Version Status
- New
- Public Device Record Key
- e845e7cb-a838-4a40-8fc3-100214fab824
Device Description
Irrigation Needle With Half Cutting Tips: 3Cc Syringe + 27G
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35970 | Dental irrigation/aspiration syringe | A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D066PGS3CC27GKIT2 | HIBCC | 20 | In Commercial Distribution | ||
| Primary | D066PGS3CC27GKIT1 | HIBCC | ||||
| Unit of Use | D066PGS3CC27GKIT0 | HIBCC |