FDA UDI
In Commercial Distribution
🇺🇸 United States
VanishPoint®
DI: 00613703110206
·
Model: 11021
·
RETRACTABLE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- VanishPoint®
- Primary DI
- 00613703110206
- Version / Model
- 11021
- Catalog Number
- 11021
- Company Name
- RETRACTABLE TECHNOLOGIES, INC.
- Labeler DUNS
- 838024255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a295fa61-f9a1-4f1a-af70-7c7dd3a3ef00
Device Description
10mL 27G x 1 1/2" VanishPoint® Syringe
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
- 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 |
|---|---|---|---|---|
| 45042 | Metered-delivery hypodermic syringe/needle | A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and 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 | 00613703110220 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 00613703110213 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00613703110206 | GS1 |
Customer Contacts
- Phone
- 888-703-1010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970803 | 000 |