FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10888551024457
·
Model: SYN399.550
·
STERILMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10888551024457
- Version / Model
- SYN399.550
- Catalog Number
- 399.55
- Company Name
- STERILMED, INC.
- Labeler DUNS
- 175899459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-18
- Public Version
- 4
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 656ae0cb-a747-46bf-acfa-3196fb7d350f
Device Description
CHISEL BLADE
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFA | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45493 | Surgical saw blade, reciprocating, single-use | A sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888551024457 | GS1 |
Customer Contacts
- Phone
- +1(888)541-0078
- [email protected]