FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Burkhart Dental Supply
DI: 00815878028441
·
Model: 72720986
·
BURKHART DENTAL SUPPLY CO., THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Burkhart Dental Supply
- Primary DI
- 00815878028441
- Version / Model
- 72720986
- Company Name
- BURKHART DENTAL SUPPLY CO., THE
- Labeler DUNS
- 027532357
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-14
- Public Version
- 3
- Public Version Date
- 2024-12-09
- Public Version Status
- Update
- Public Device Record Key
- 0bec6f73-6106-4071-81f8-35dbadb20de2
- Distribution End Date
- 2024-11-01
Device Description
Burkhart Green SM Chloroprene PF Txt Gloves (200)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OPC | Powder-Free Polychloroprene Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56288 | Polychloroprene examination/treatment glove, non-powdered | A device made of polychloroprene (neoprene) 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 patient/staff against contaminants and risk of allergy to 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 |
|---|---|---|---|---|---|---|
| Primary | 00815878028441 | GS1 |
Customer Contacts
- Phone
- 800-562-8176
- [email protected]