FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMBITEX
DI: 00699320102152
·
Model: LXL800
·
Tradex International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- AMBITEX
- Primary DI
- 00699320102152
- Version / Model
- LXL800
- Catalog Number
- LXL800
- Company Name
- Tradex International, Inc.
- Labeler DUNS
- 196027981
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-04-22
- Public Version
- 7
- Public Version Date
- 2024-03-01
- Public Version Status
- Update
- Public Device Record Key
- b65c68f0-cc25-43ec-8696-a5801d385382
- Distribution End Date
- 2024-03-01
Device Description
AMBITEX GLV EXAM NON-STERILE LATEX DURASILK L800 CREAM POWDER-FREE EXTRA LARGE FINGER TEXTURED STANDARD LENGTH 10/100
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| LYY | Latex patient examination glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47172 | Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial | A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10699320102159 | GS1 | CASE | 10 | Not in Commercial Distribution | 2024-03-01 |
| Primary | 00699320102152 | GS1 | ||||
| Unit of Use | 30699320102153 | GS1 |