FDA UDI
In Commercial Distribution
🇺🇸 United States
Alleset
DI: 16931918190211
·
Model: 30-04037-S
·
GRI Medical & Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Alleset
- Primary DI
- 16931918190211
- Version / Model
- 30-04037-S
- Company Name
- GRI Medical & Electronic Technology Co., Ltd.
- Labeler DUNS
- 679894738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2023-05-22
- Public Version
- 1
- Public Version Date
- 2023-05-30
- Public Version Status
- New
- Public Device Record Key
- d158c9ed-2ecb-4c35-954f-4e71d9d7b4bd
Device Description
Needle Counter_Red_40-Count_Foam Block_Magnet_Sterile_50 ea/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 |
|---|---|---|---|---|
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61634 | Sharp surgical instrument counting tray/pad, single-use | A device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26931918190218 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 16931918190211 | GS1 | ||||
| Unit of Use | 06931918190214 | GS1 |
Customer Contacts
- Phone
- +86057383617385
- [email protected]