FDA UDI
In Commercial Distribution
🇺🇸 United States
SureFine Pen Needle 31Gx8mm
DI: 08800052600669
·
Model: SM-0018
·
SHINA MED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
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Basic Information
- Brand Name
- SureFine Pen Needle 31Gx8mm
- Primary DI
- 08800052600669
- Version / Model
- SM-0018
- Company Name
- SHINA MED CORPORATION
- Labeler DUNS
- 689061990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-05-01
- Public Version
- 1
- Public Version Date
- 2019-05-09
- Public Version Status
- New
- Public Device Record Key
- 59ee72f1-a861-4bb1-8ffa-5d91910e6c14
Device Description
SureFine Pen Needle 31Gx8mm 100pcs per Box
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
- No
- 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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 | 08800052600683 | GS1 | Master Case | 6 | In Commercial Distribution | |
| Package | 08800052600676 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 08800052600669 | GS1 | ||||
| Unit of Use | 8800052600669 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152877 | 000 |