FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW Short Stem Humeral System
DI: 03661489711190
·
Model: 271119- ARROW COUVERCLE UNIVERSEL
·
FOURNITURES HOSPITALIERES INDUSTRIE
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW Short Stem Humeral System
- Primary DI
- 03661489711190
- Version / Model
- 271119- ARROW COUVERCLE UNIVERSEL
- Company Name
- FOURNITURES HOSPITALIERES INDUSTRIE
- Labeler DUNS
- 261839898
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-28
- Public Version
- 1
- Public Version Date
- 2022-02-07
- Public Version Status
- New
- Public Device Record Key
- b22b7acd-8298-42be-961d-3fe3c3087901
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | 888.3660 | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | 888.3690 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65582 | Instrument tray cover, reusable | A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661489711190 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202024 | 000 |