FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambler Surgical
DI: 00190660050191
·
Model: 29-140
·
AMBLER SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ambler Surgical
- Primary DI
- 00190660050191
- Version / Model
- 29-140
- Catalog Number
- 29-140
- 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
- 57f264df-200d-4648-9d44-d7873c660e43
Device Description
DeBakey vascular tissue forceps, 7 3/4", standard, straight, 2.0mm tapered atraumatic tips, flat 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 |
|---|---|---|---|---|
| DXC | CLAMP, VASCULAR | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11785 | Intestinal forceps | A hand-held manual surgical instrument designed for the atraumatic holding/grasping and/or compression of intestinal structures, tissues, and some organs during a surgical procedure. It typically has two main designs: 1) a self-retaining, scissors-like design with ring handles; or 2) a large tweezers-like design with straight blades that are conjoined at the proximal end. It is available in various sizes and the working end can terminate in a variety of blade designs (e.g., loops or triangles that have parallel grooves or serrations for grip, or inward curved profiles to grasp over or around). It is made of high-grade stainless steel. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190660050191 | GS1 |
Customer Contacts
- Phone
- +1(888)407-0006 ext. 0
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092544 | 000 |