FDA UDI
In Commercial Distribution
🇺🇸 United States
BRIDGEMASTER®
DI: 20681490138622
·
Model: 600302
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- BRIDGEMASTER®
- Primary DI
- 20681490138622
- Version / Model
- 600302
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-09-09
- Public Version
- 4
- Public Version Date
- 2021-03-01
- Public Version Status
- Update
- Public Device Record Key
- 92401538-daa8-47b8-84de-f60794838ca6
Device Description
SPLINT 600302 BRIDGEMASTER 5PK SMALL
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EPP | SPLINT, NASAL | Ear, Nose, Throat | 874.5800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35411 | External nasal splint | A rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20681490138622 | GS1 | ||||
| Unit of Use | 00681490138628 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]