FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551168103
·
Model: 49310DE
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048551168103
- Version / Model
- 49310DE
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 93b03fdb-dc05-4a2a-b5d5-079af7946da6
Device Description
Inner Rod, for 49310DA
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 |
|---|---|---|---|---|
| 34947 | Aorta clamp | A hand-held manual surgical instrument designed for the temporary, atraumatic compression of the aorta for haemostasis (arrest or prevention of bleeding) during a procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and the working end can have a wide variety of blade designs (e.g., curved, angled, semicircular) specific to different applications (e.g., used as an aorta cross clamp, an aorta aneurysm clamp, or an aorta anastomosis clamp). This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551168103 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014277 | 000 |