FDA UDI
In Commercial Distribution
🇺🇸 United States
Anterior Spinal Instrument Tray
DI: 10840199544117
·
Model: 7580-00
·
KOROS U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Anterior Spinal Instrument Tray
- Primary DI
- 10840199544117
- Version / Model
- 7580-00
- Catalog Number
- 7580-00
- Company Name
- KOROS U.S.A., INC.
- Labeler DUNS
- 007928633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-31
- Public Version
- 1
- Public Version Date
- 2022-11-08
- Public Version Status
- New
- Public Device Record Key
- 4bedec67-ec52-4d30-846b-6ec919b53782
Device Description
Anterior Spinal Instrument Tray Consists of the Following: 1 x 7331-10, 1 x 7331-20, 1 x 7331-22, 1 x 7331-30, 1 x 7331-40, 1 x 7331-50, 1 x 7331-60, 1 x 7331-70-, 1 x 7331-90, 1 x 7386-20, 1 x 7386-30, 1 x 7386-40, 1 x 7386-50, 1 x 7388-20, 1 x 7388-30, 1 x 7388-40, 1 x 7388-50, 1 x 7389-20, 1 x 7389-30, 1 x 7389-40, 1 x 7389-52, 1 x 7349-10, 1 x 7349-20, 1 x 7349-30, 1 x 7349-12, 1 x 7349-22, 1 x 7349-32, 1 x 7462-06, 1 x 7462-09, 1 x 7462-12, 1 x 7462-16 & 1 x 7462-19
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| HTE | Elevator | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35559 | Bone file/rasp, manual, reusable | A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00840199544110 | GS1 | ||||
| Primary | 10840199544117 | GS1 |
Customer Contacts
- Phone
- 1-805-529-0825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3mm tip |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place at room temperature