FDA UDI
In Commercial Distribution
🇺🇸 United States
The Orthodontic Store
DI: 00840326415917
·
Model: 22502
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- The Orthodontic Store
- Primary DI
- 00840326415917
- Version / Model
- 22502
- Catalog Number
- 22502
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-02
- Public Version
- 1
- Public Version Date
- 2022-11-10
- Public Version Status
- New
- Public Device Record Key
- f913dab5-eb43-41a9-8334-bcaf15a73873
Device Description
Cherry Flavored Powder-Free Latex Gloves - Small
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 47509 | Guayule-latex examination/treatment glove, non-powdered | A non-sterile device made of guayule 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 talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination and risk of allergy to Hevea-latex. 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 | 10840326415914 | GS1 | Inner Pack | 100 | In Commercial Distribution | |
| Primary | 00840326415917 | GS1 | ||||
| Package | 20840326415911 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]