FDA UDI
In Commercial Distribution
🇺🇸 United States
Clearline
DI: B971CL301
·
Model: 3.0mm Clearline wire on diamond label
·
Jessop Precision Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
165
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Basic Information
- Brand Name
- Clearline
- Primary DI
- B971CL301
- Version / Model
- 3.0mm Clearline wire on diamond label
- Company Name
- Jessop Precision Products Inc.
- Labeler DUNS
- 055127831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 165
- Record Status
- Published
- Publish Date
- 2021-10-08
- Public Version
- 1
- Public Version Date
- 2021-10-18
- Public Version Status
- New
- Public Device Record Key
- 0678dd17-326a-47b8-9c85-843a6d29a975
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | 892.1640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61577 | Skin marking sticker | A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B971CL300 | HIBCC | ||||
| Primary | B971CL301 | HIBCC |
Customer Contacts
- Phone
- 800-406-3399
- [email protected]