FDA UDI
In Commercial Distribution
🇺🇸 United States
KOMET Surgical Saw Blade
DI: 14053613201749
·
Model: KM71125.C62..M0
·
Gebr. Brasseler GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- KOMET Surgical Saw Blade
- Primary DI
- 14053613201749
- Version / Model
- KM71125.C62..M0
- Catalog Number
- KM71125.C62.
- Company Name
- Gebr. Brasseler GmbH & Co. KG
- Labeler DUNS
- 317409001
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-29
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- 94a521c7-9d2f-4396-a373-9c1ad9c695e1
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
- 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 |
|---|---|---|---|---|
| GFA | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44986 | Sternum saw blade, reusable | A flat metal surgical instrument with a serrated edge intended to be attached to a dedicated powered surgical saw for cutting the sternum (the breastbone) during cardiovascular surgery. It is available in various forms (e.g., straight or arc-shaped) and is powered by a rapid reciprocating, oscillating or sagittal motion provided by the saw. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24053613201746 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 14053613201749 | GS1 | ||||
| Direct Marking | 04053613201742 | GS1 |