FDA UDI
In Commercial Distribution
🇺🇸 United States
Qlicksmart SnapIT Trolley Regular
DI: 09337363001544
·
Model: TE-01R
·
QLICKSMART PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Qlicksmart SnapIT Trolley Regular
- Primary DI
- 09337363001544
- Version / Model
- TE-01R
- Company Name
- QLICKSMART PTY LTD
- Labeler DUNS
- 755003498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-18
- Public Version
- 2
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 55d949e6-15eb-4d86-b628-5f26efbce0ac
Device Description
Qlicksmart’s SnapIT ampoule openers are designed to protect you from cuts when opening a glass ampoule.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10098 | Ampule opener | A cutting instrument intended to safely remove/break the protective, sterile seal of an ampule. It is typically designed to protect the user from inadvertent contact with the sharp edges of the seal while being removed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 59337363001549 | GS1 | Outer Carton | 12 | In Commercial Distribution | |
| Package | 49337363001542 | GS1 | Inner Box | 10 | In Commercial Distribution | |
| Primary | 09337363001544 | GS1 |