FDA UDI
In Commercial Distribution
🇺🇸 United States
GEN2
DI: 00840343712464
·
Model: G2N77873
·
SURGIX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GEN2
- Primary DI
- 00840343712464
- Version / Model
- G2N77873
- Catalog Number
- G2N77873
- Company Name
- SURGIX MEDICAL LLC
- Labeler DUNS
- 080402644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-24
- Public Version
- 1
- Public Version Date
- 2022-11-01
- Public Version Status
- New
- Public Device Record Key
- 553f047a-3eb7-4e0f-8370-37c4d53111f1
Device Description
CASPAR IVD, TEETH, 6X16MM, STR 7.25"
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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAE | Rongeur, Manual | Neurology | 882.4840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35541 | Spinal rongeur | A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840343712464 | GS1 | ||||
| Previous | G277G2N778730 | HIBCC |
Customer Contacts
- Phone
- 888-247-0477
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.25 | Inch | |
| Device Size Text, specify | Direction Straight | ||
| Device Size Text, specify | Tip Width 6MM | ||
| Device Size Text, specify | Tip Length 16MM |