FDA UDI
In Commercial Distribution
🇺🇸 United States
Dukal
DI: 00665973000404
·
Model: CT-02B
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Dukal
- Primary DI
- 00665973000404
- Version / Model
- CT-02B
- Catalog Number
- CT-02B
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2017-09-15
- Public Version
- 8
- Public Version Date
- 2022-05-23
- Public Version Status
- Update
- Public Device Record Key
- fd8076fb-b27e-4436-acde-9bccbbb08bb9
Device Description
DK OR TowelCSR WrapSoftpack,ST16"x26"Blue
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | FIBER, MEDICAL, ABSORBENT | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45171 | Dry medical towel/wipe, single-use | A dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20665973000408 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 00665973000404 | GS1 | ||||
| Unit of Use | 10665973000401 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800
- [email protected]