FDA UDI
In Commercial Distribution
🇺🇸 United States
I.C.U. MITCHELL TUBE SPREADER
DI: 00192896038707
·
Model: 442-877
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- I.C.U. MITCHELL TUBE SPREADER
- Primary DI
- 00192896038707
- Version / Model
- 442-877
- Catalog Number
- 442-877
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-11
- Public Version
- 3
- Public Version Date
- 2026-03-05
- Public Version Status
- Update
- Public Device Record Key
- 246fceed-7256-4279-bda2-63f79f4a496f
Device Description
I.C.U. MITCHELL TUBE SPREADER
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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32146 | Medical tubing clip/clamp, temporary, non-calibrated, reusable | A non-sterile, manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896038707 | GS1 |
Customer Contacts
- Phone
- +1(800)821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 90 Degree Tip | ||
| Length | 5.25 | Inch |