FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Silverstein
DI: 20681490040765
·
Model: 1425020
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Silverstein
- Primary DI
- 20681490040765
- Version / Model
- 1425020
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2017-10-13
- Public Version
- 5
- Public Version Date
- 2023-08-30
- Public Version Status
- Update
- Public Device Record Key
- b8299b43-982a-4cc5-8df3-ab8cabcce6cf
- Distribution End Date
- 2018-10-24
Device Description
PACKING 1425020 6PK REG STRIPS FLPL
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NOK | MATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE | General, Plastic Surgery | 878.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33310 | Polyethylene craniofacial tissue reconstructive material | A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20681490040765 | GS1 | ||||
| Unit of Use | 00681490040761 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]