FDA UDI
In Commercial Distribution
🇺🇸 United States
OptiClear Sleeves
DI: B9764488081
·
Model: 448808
·
Minitube AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- OptiClear Sleeves
- Primary DI
- B9764488081
- Version / Model
- 448808
- Company Name
- Minitube AB
- Labeler DUNS
- 775295061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-02-13
- Public Version
- 1
- Public Version Date
- 2026-02-23
- Public Version Status
- New
- Public Device Record Key
- b663a43a-ce1a-4c31-b9cf-11fd923e0017
Device Description
Disposable protective sheaths for intraoral cameras. Non-sterile. Single-use only.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). 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 |
|---|---|---|---|---|---|---|
| Primary | B9764488081 | HIBCC | ||||
| Unit of Use | B9764488101 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211026 | 000 |