FDA UDI
In Commercial Distribution
🇺🇸 United States
PlastCare
DI: D066PGBARBLK1
·
Model: PG-BAR-BLK
·
Proguard Health, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PlastCare
- Primary DI
- D066PGBARBLK1
- Version / Model
- PG-BAR-BLK
- Catalog Number
- PG-BAR-BLK
- Company Name
- Proguard Health, Inc
- Labeler DUNS
- 129529337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- b4951593-fdad-4987-8364-85ef591a2253
Device Description
Barrier Film Black
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 |
|---|---|---|---|---|
| IWX | Barrier, Control Panel, X-Ray, Movable | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61057 | Implantable-device infection control barrier | A sterile, bioabsorbable, implantable substance intended to be applied as a protective barrier over the surface of an implantable device (e.g., orthopaedic prosthesis) prior to implantation to prevent bacterial adhesion, colonization, and biofilm formation through physical means only; it may be used in conjunction with a separate antimicrobial agent. It contains microbe-derived materials [e.g., hyaluronic acid (HA)] and may be supplied in dry form (e.g., powder) intended to be hydrated prior to use; disposable devices associated with application/preparation (e.g., syringes, adaptors, application nozzle) may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D066PGBARBLK2 | HIBCC | 8 | In Commercial Distribution | ||
| Primary | D066PGBARBLK1 | HIBCC |