FDA UDI
In Commercial Distribution
🇺🇸 United States
VanishPoint®
DI: 00613703102102
·
Model: 10211
·
RETRACTABLE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- VanishPoint®
- Primary DI
- 00613703102102
- Version / Model
- 10211
- Catalog Number
- 10211
- 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
- 4
- Public Version Date
- 2026-03-18
- Public Version Status
- Update
- Public Device Record Key
- 107a7487-6ac0-40e9-878c-f48f61eb1bdc
Device Description
1mL 29G x 1/2" Insulin 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 |
|---|---|---|---|---|
| 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 |
| 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 | 00613703102126 | GS1 | Case | 8 | In Commercial Distribution | |
| Package | 00613703102119 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00613703102102 | GS1 |
Customer Contacts
- Phone
- 888-703-1010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973301 | 000 |