FDA UDI
In Commercial Distribution
🇺🇸 United States
Bausch Y-Holder
DI: E210BK14008
·
Model: BK 140
·
Dr. Jean Bausch GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bausch Y-Holder
- Primary DI
- E210BK14008
- Version / Model
- BK 140
- Company Name
- Dr. Jean Bausch GmbH & Co. KG
- Labeler DUNS
- 321624272
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-20
- Public Version
- 1
- Public Version Date
- 2019-12-30
- Public Version Status
- New
- Public Device Record Key
- c655b3ca-464d-4780-b3ce-d24b38b08089
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFK | Forceps, Articulation Paper | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31813 | Dental articulation paper forceps | A hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E210BK14008 | HIBCC |