FDA UDI
In Commercial Distribution
🇺🇸 United States
CLIP 9 VITALITEC
DI: 03661522039533
·
Model: O9120
·
PETERS SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- CLIP 9 VITALITEC
- Primary DI
- 03661522039533
- Version / Model
- O9120
- Catalog Number
- O9120
- Company Name
- PETERS SURGICAL
- Labeler DUNS
- 265741780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-31
- Public Version
- 3
- Public Version Date
- 2023-07-12
- Public Version Status
- Update
- Public Device Record Key
- 725960f9-e35b-4eb1-9e17-7c17e02f8358
Device Description
Titanium Hemostatic Clip - Large Size
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FZP | Clip, Implantable | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35649 | Ligation clip, metallic | A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 03661624004835 | GS1 | ||||
| Package | 13661522039530 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 03661522039533 | GS1 |
Customer Contacts
- Phone
- +1 508-747-6033
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | large |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the unopened sterile package in a cool, dry area, with good ventilation away from areas of extreme temperature and humidity.