FDA UDI
In Commercial Distribution
🇺🇸 United States
DEPUY STYLE CAN GLEN REMR LG
DI: 00889024581067
·
Model: SSI005296
·
Biomet Orthopedics, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DEPUY STYLE CAN GLEN REMR LG
- Primary DI
- 00889024581067
- Version / Model
- SSI005296
- Catalog Number
- SSI005296
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-03
- Public Version
- 1
- Public Version Date
- 2020-02-11
- Public Version Status
- New
- Public Device Record Key
- 546d0d63-7a51-4e6f-94a9-a7d62d5a5de9
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3650 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45116 | Tooth dryer | A device used in general and orthodontic dentistry to dry the surface of a tooth undergoing treatment prior to the application of dental products (e.g., adhesives, composites, sealants). The device provides pure warm air (free from contaminants) directly to the site of intervention, and is typically designed like a dental handpiece so that the operator can access any tooth within the oral cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024581067 | GS1 |
Customer Contacts
- Phone
- 1 (800) 343-9500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | LG |