FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632126857
·
Model: SURL048
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632126857
- Version / Model
- SURL048
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-12
- Public Version
- 1
- Public Version Date
- 2020-10-20
- Public Version Status
- New
- Public Device Record Key
- af9ace8d-dada-450e-836e-a16e8165c05a
Device Description
Marker Skin And Utility With 6 Inch Flexible Ruler 48 Pre-Printed Label Black Not Made With Natural Rubber Latex MediChoice
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZZ | MARKER, SKIN | General, Plastic Surgery | 878.4660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61575 | Skin marking pen, single-use | A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632126855 | GS1 | 12 | In Commercial Distribution | ||
| Package | 30885632126851 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 10885632126857 | GS1 |