FDA UDI
In Commercial Distribution
🇺🇸 United States
Suremark Left
DI: B971SLLEFT1
·
Model: 1.2cm (0.5 inch) Left "L" Marker on disposable label
·
Jessop Precision Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Suremark Left
- Primary DI
- B971SLLEFT1
- Version / Model
- 1.2cm (0.5 inch) Left "L" Marker on disposable label
- Company Name
- Jessop Precision Products Inc.
- Labeler DUNS
- 055127831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- 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
- 1d657409-6370-420a-8a21-39eb1bfeff94
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| 40806 | Radiographic image marker, automatic | A camera or image formatting unit that is a component of a diagnostic imaging system used to imprint identifying marks on: 1) photographic film or x-ray film (by exposure to visible light); or 2) digitally, on images created using various diagnostic imaging modalities [e.g., magnetic resonance imaging (MRI), x-ray or nuclear medicine]. Depending on the design of the marking system, it may be electronically or computer-controlled. Most frequently, it is used to imprint information on the images related to image acquisition parameters, patient identification, and to record anatomical information on individual images. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B971SLLEFT0 | HIBCC | ||||
| Primary | B971SLLEFT1 | HIBCC |
Customer Contacts
- Phone
- 800-406-3399
- [email protected]