FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambler Surgical
DI: 00190660079987
·
Model: 34-343
·
AMBLER SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ambler Surgical
- Primary DI
- 00190660079987
- Version / Model
- 34-343
- Catalog Number
- 34-343
- Company Name
- AMBLER SURGICAL CORP.
- Labeler DUNS
- 015272206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3bfeaf09-f3bd-4343-b634-c41fcfe9d5b4
Device Description
Z-Type hysterectomy (Parametrium) clamp forceps, 12", angled, serrated jaws, ring handle
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 |
|---|---|---|---|---|
| 44538 | Hysterectomy forceps, reusable | A hand-held manual surgical instrument intended for the grasping, pulling or compression of the uterus during a hysterectomy (for the removal of the womb and the necessary associated organs). 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 and the working end can have a variety of blade designs, e.g., straight or curved; some types may have an additional grasping claw at the distal end. The blades are heavily serrated or may have a profiled longitudinal groove to provide extra grip of the organ. Also known as a parametrium clamp or vaginal clamp. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190660079987 | GS1 |
Customer Contacts
- Phone
- +1(888)407-0006 ext. 0
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092840 | 000 |