FDA UDI
In Commercial Distribution
🇺🇸 United States
ProBarrier
DI: H816MBB0528X1
·
Model: BB-0528X
·
MicroCare, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
250
Basic Information
- Brand Name
- ProBarrier
- Primary DI
- H816MBB0528X1
- Version / Model
- BB-0528X
- Catalog Number
- BB-0528X-1
- Company Name
- MicroCare, LLC
- Labeler DUNS
- 118518186
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2022-10-26
- Public Version
- 2
- Public Version Date
- 2023-08-30
- Public Version Status
- Update
- Public Device Record Key
- 5d95f848-cdb6-4bab-b789-b440843b2438
Device Description
Environmental Surface Barrier, 5 x 28 Instrument/equipment drape, x-ray sox
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | Dental | 872.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H816MBB0528X2 | HIBCC | Case Box | 10 | Not in Commercial Distribution | 2023-08-28 |
| Primary | H816MBB0528X1 | HIBCC | ||||
| Unit of Use | H816MBB0528X0 | HIBCC | ||||
| Previous | H816BB0528X1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922175 | 000 |