FDA UDI
In Commercial Distribution
🇺🇸 United States
PlastCare
DI: D066PGSTRS15261
·
Model: PG-STR-S1526
·
Proguard Health, Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- PlastCare
- Primary DI
- D066PGSTRS15261
- Version / Model
- PG-STR-S1526
- Catalog Number
- PG-STR-S1526
- Company Name
- Proguard Health, Inc
- Labeler DUNS
- 129529337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- 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
- 4901f1c2-7a3f-480f-b95b-f9b0620e3d89
Device Description
X-Ray Head Sleeves (15" x 26")
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 |
|---|---|---|---|---|
| FRK | Chair, Examination And Treatment | General Hospital | 880.6140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47144 | Dental chair, electric | A mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D066PGSTRS15262 | HIBCC | 4 | In Commercial Distribution | ||
| Primary | D066PGSTRS15261 | HIBCC | ||||
| Unit of Use | D066PGSTRS15260 | HIBCC |