FDA UDI
In Commercial Distribution
🇺🇸 United States
Stealth® Soft/Fibra® Spring Clip
DI: 00607915110628
·
Model: A1654
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Stealth® Soft/Fibra® Spring Clip
- Primary DI
- 00607915110628
- Version / Model
- A1654
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-06-19
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- fa79d278-0e64-4ec3-ac53-70dadd07577d
Device Description
1/4 Force Surgical Spring Clip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSS | Clip, Vascular | Cardiovascular | 870.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62480 | Surgical bulldog clamp, single-use | 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 plastic. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607915110625 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00607915110628 | GS1 |
Customer Contacts
- Phone
- 1.949.713.8300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6 | Millimeter |