FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrument Case
DI: 10840199536952
·
Model: 8797-90
·
KOROS U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Instrument Case
- Primary DI
- 10840199536952
- Version / Model
- 8797-90
- Catalog Number
- 8797-90
- 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
- 2022-08-01
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 72b3b2e6-e3e4-4db2-9a9e-827004f6e735
Device Description
Quick Change Instrument Case
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 |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00840199536955 | GS1 | ||||
| Primary | 10840199536952 | GS1 |
Customer Contacts
- Phone
- 1-805-529-0825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 9x12mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place at room temperature