FDA UDI
In Commercial Distribution
🇺🇸 United States
Klein Surgical
DI: 10850048763262
·
Model: 300-100-778
·
Klein Surgical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Klein Surgical
- Primary DI
- 10850048763262
- Version / Model
- 300-100-778
- Catalog Number
- 300-100-778
- Company Name
- Klein Surgical Systems, Inc.
- Labeler DUNS
- 072364974
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-17
- Public Version
- 1
- Public Version Date
- 2023-07-25
- Public Version Status
- New
- Public Device Record Key
- 34584025-9cb2-40f7-bfa0-da00412642f3
Device Description
Klein Bulldog Clamp 45mm Curved
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 |
|---|---|---|---|---|
| GCI | Laryngoscope, Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62470 | Surgical bulldog clamp, reusable | A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850048763262 | GS1 |
Customer Contacts
- Phone
- 210-280-4324
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930496 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Millimeter |