FDA UDI
In Commercial Distribution
🇺🇸 United States
E-Z-Mark
DI: 30815112021505
·
Model: 901003
·
Bracco Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
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Basic Information
- Brand Name
- E-Z-Mark
- Primary DI
- 30815112021505
- Version / Model
- 901003
- Catalog Number
- 901003
- Company Name
- Bracco Diagnostics Inc.
- Labeler DUNS
- 849234661
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2026-01-09
- Public Version
- 1
- Public Version Date
- 2026-01-19
- Public Version Status
- New
- Public Device Record Key
- 99f686bf-d18d-435f-b666-31a59b17764f
Device Description
Marker
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 66941 | Radiological image marker, noninvasive, single-use | A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker or clip, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30815112021505 | GS1 | ||||
| Package | 50815112021509 | GS1 | Shipper box | 60 | In Commercial Distribution | |
| Unit of Use | 00815112021504 | GS1 |
Customer Contacts
- Phone
- 609-514-2200
- [email protected]