FDA UDI
In Commercial Distribution
🇺🇸 United States
COTTLE CARTILAGE CRUSHER
DI: 00192896032002
·
Model: 350-844
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- COTTLE CARTILAGE CRUSHER
- Primary DI
- 00192896032002
- Version / Model
- 350-844
- Catalog Number
- 350-844
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- d35f987e-f1c1-4c54-ac3d-8b8ee2682828
Device Description
COTTLE CARTILAGE CRUSHER DOUBLE SIDED
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 |
|---|---|---|---|---|
| HWN | INSTRUMENT, COMPRESSION | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62924 | Surgical tissue compression device | A manual compression device designed to flatten, compact, or sculpt implantable tissues and tissue reconstructive materials (e.g., bone, cartilage, bone/fascia graft, gel foam) prior to their use in a surgical procedure. It may be referred to as a tissue crusher and is typically in the form of two hinged plates with a tightening mechanism (e.g., screws) to press the plates together with the material between, or a pliers-like device with jaws that compress. It is typically made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896032002 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]