FDA UDI
In Commercial Distribution
🇺🇸 United States
Alleset
DI: 16931918142616
·
Model: TUF019
·
GRI Medical & Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Alleset
- Primary DI
- 16931918142616
- Version / Model
- TUF019
- Company Name
- GRI Medical & Electronic Technology Co., Ltd.
- Labeler DUNS
- 679894738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-25
- Public Version
- 1
- Public Version Date
- 2024-10-03
- Public Version Status
- New
- Public Device Record Key
- 76702cd6-32dc-45b9-9010-b063f6a076be
Device Description
Arterial Pack_Sterile_2EA/CS
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| OEZ | Cardiovascular Procedure Kit | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66336 | Non-dedicated vascular surgical procedure kit | A collection of various surgical instruments and supportive devices/materials intended to support multiple types of vascular surgical/access procedures (non-dedicated); it is not intended to support a catheterization procedure. It typically includes devices such as syringes, needles, scalpel, swabs, dressings, and drapes; it does not include any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26931918142613 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 16931918142616 | GS1 |
Customer Contacts
- Phone
- +86057383617385
- [email protected]