FDA UDI
In Commercial Distribution
🇺🇸 United States
Alleset
DI: 16931918177526
·
Model: 25-2008
·
GRI Medical & Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Alleset
- Primary DI
- 16931918177526
- Version / Model
- 25-2008
- Company Name
- GRI Medical & Electronic Technology Co., Ltd.
- Labeler DUNS
- 679894738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2022-11-14
- Public Version
- 1
- Public Version Date
- 2022-11-22
- Public Version Status
- New
- Public Device Record Key
- 3a55fb9d-cced-4c79-8d39-5daf8afa003a
Device Description
Sponge prep stick_Blue sponge and white prep stick_ bulk packaged_1000ea/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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15281 | Surgical scrub sponge | A hand-held device that includes an absorbent, porous material designed to wash the skin of the arms, hands, and the fingernails in preparation for a medical/surgical procedure. It is typically multilayered and impregnated with an antimicrobial solution. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 06931918177529 | GS1 | ||||
| Primary | 16931918177526 | GS1 |
Customer Contacts
- Phone
- +86057383617385
- [email protected]