FDA UDI
In Commercial Distribution
🇺🇸 United States
THERMOPLASTIC INSTRUMENT TRAY
DI: 00192896053366
·
Model: 1103-715
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- THERMOPLASTIC INSTRUMENT TRAY
- Primary DI
- 00192896053366
- Version / Model
- 1103-715
- Catalog Number
- 1103-715
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-10
- Public Version
- 8
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 7829525b-e9b3-457e-87f5-62b620a8dc40
Device Description
THERMOPLASTIC INSTRUMENT TRAY DOUBLE DECKER WITH SILICONE MAT
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
- 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
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Dry Heat 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 |
|---|---|---|---|---|---|---|
| Primary | 00192896053366 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Inch | |
| Height | 1.5 | Inch | |
| Length | 10 | Inch |