FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure™
DI: 10840330703663
·
Model: PCSS740
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ProCure™
- Primary DI
- 10840330703663
- Version / Model
- PCSS740
- Catalog Number
- PCSS740
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-04
- Public Version
- 1
- Public Version Date
- 2023-10-12
- Public Version Status
- New
- Public Device Record Key
- 6eeb54ea-74b7-4596-a161-92bdd9209e2e
Device Description
ProCure Safe TB Tuberculin Safety Syringe 1ml 28g x 1/2" - 100ea/bx 8bx/cs
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
- 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 |
|---|---|---|---|---|
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34973 | Insulin syringe/needle, safety | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330703667 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 10840330703663 | GS1 | ||||
| Package | 50840330703661 | GS1 | Case | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 612-819-1635
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150758 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.5 | Inch | |
| Needle Gauge | 28 | Gauge | |
| Outer Diameter | .5 | Inch | |
| Total Volume | 1 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry, Keep away from Direct Sunlight
- Type
- Handling Environment Temperature
- Temperature Range
- – 104 Degrees Fahrenheit