FDA UDI
In Commercial Distribution
🇺🇸 United States
GEN2
DI: 00840343713935
·
Model: G2OB1554
·
SURGIX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GEN2
- Primary DI
- 00840343713935
- Version / Model
- G2OB1554
- Catalog Number
- G2OB1554
- Company Name
- SURGIX MEDICAL LLC
- Labeler DUNS
- 080402644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-09
- Public Version
- 1
- Public Version Date
- 2023-01-17
- Public Version Status
- New
- Public Device Record Key
- 171bf713-4d99-4f95-822b-36b424a2ab48
Device Description
JACOBS UTERINE VULSELLUM FORCEPS SERR CVD
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 |
|---|---|---|---|---|
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13998 | Uterine tenaculum | A hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840343713935 | GS1 |
Customer Contacts
- Phone
- 888-247-0477
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092840 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8.25 | Inch | |
| Device Size Text, specify | Tip Width 7MM |