FDA UDI
In Commercial Distribution
🇺🇸 United States
SyringePro
DI: 00860003864708
·
Model: 10mLNSSU
·
SLANTED ADAPTOR LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- SyringePro
- Primary DI
- 00860003864708
- Version / Model
- 10mLNSSU
- Catalog Number
- 10mLNSSU
- Company Name
- SLANTED ADAPTOR LLC
- Labeler DUNS
- 074078018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-11-10
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 901f6dd6-6146-4560-ade7-1aae9c11d820
Device Description
10-12 mL Standard Syringe Size, Non-sterile, Single-Use, syringe adaptor. Single patient visit use. Count 20. Syringe accessory for comfort and ergonomic support
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IQG | Adaptor, Holder, Syringe | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12132 | Syringe-loaded medication/vaccine injector, manual, professional | A hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003864708 | GS1 | ||||
| Unit of Use | 00860003864715 | GS1 |
Customer Contacts
- Phone
- 5625462811
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 130 Degrees Fahrenheit