FDA UDI
In Commercial Distribution
🇺🇸 United States
Coborn's/UltiGuard
DI: 20357515035633
·
Model: 09563CB
·
ULTIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Coborn's/UltiGuard
- Primary DI
- 20357515035633
- Version / Model
- 09563CB
- Company Name
- ULTIMED, INC.
- Labeler DUNS
- 024723541
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-10-18
- Public Version
- 1
- Public Version Date
- 2019-10-28
- Public Version Status
- New
- Public Device Record Key
- 0ae7ad66-9b63-41dc-9875-1254285f56e7
Device Description
6mm Coborn's UltiGuard Safe Pack Pen Needles
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44127 | Autoinjector needle | A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30357515035630 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 20357515035633 | GS1 | ||||
| Unit of Use | 00357515710147 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100812 | 000 |