FDA UDI
In Commercial Distribution
🇺🇸 United States
Invotec
DI: B504GS60450500
·
Model: 60-45050
·
Provision
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Invotec
- Primary DI
- B504GS60450500
- Version / Model
- 60-45050
- Company Name
- Provision
- Labeler DUNS
- 016889401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-30
- Public Version
- 1
- Public Version Date
- 2024-10-08
- Public Version Status
- New
- Public Device Record Key
- 187e8db6-3cd5-4c33-8ef7-7b54c6f67f96
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GES | Blade, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63598 | Surgical saw blade, reciprocating, reprocessed | A flat surgical cutting instrument 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 (not a dedicated sternum saw blade). It 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 that has previously been used on a patient and has been reprocessed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B504GS60450500 | HIBCC |
Customer Contacts
- Phone
- 541-508-7520
- [email protected]