FDA UDI
In Commercial Distribution
🇺🇸 United States
Dukal
DI: 30665973027211
·
Model: 27604-BK
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Dukal
- Primary DI
- 30665973027211
- Version / Model
- 27604-BK
- Catalog Number
- 27604-BK
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 2
- Public Version Date
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- 23df1afc-18c7-4e2f-8139-fc8fc105e57c
Device Description
Barrier Film, 4"x6" sheets, Clear
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| PEM | Dental barriers and sleeves | General, Plastic Surgery | 878.4370 | 2 |
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00665973027210 | GS1 | ||||
| Primary | 30665973027211 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183263 | 000 |