FDA UDI
In Commercial Distribution
🇺🇸 United States
Unifine OTC
DI: 00761059651000
·
Model: AN 3651
·
OWEN MUMFORD USA INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Unifine OTC
- Primary DI
- 00761059651000
- Version / Model
- AN 3651
- Company Name
- OWEN MUMFORD USA INCORPORATED
- Labeler DUNS
- 803401454
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-02-14
- Public Version
- 1
- Public Version Date
- 2025-02-24
- Public Version Status
- New
- Public Device Record Key
- d65faa0e-7c96-4364-ac60-2ea84a1749a2
Device Description
Unifine OTC Pen Needle, 5mm x 31G, 50 ct
Device Characteristics
- Single Use
- Yes
- 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
- 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 | 00761059651031 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00761059651000 | GS1 | ||||
| Unit of Use | 00384703550001 | GS1 |
Customer Contacts
- Phone
- 770-977-2226
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152339 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 31 | Gauge | |
| Length | 5 | Millimeter |