FDA UDI
In Commercial Distribution
🇺🇸 United States
ZIPCLIP
DI: 00844735006384
·
Model: 529500001061
·
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ZIPCLIP
- Primary DI
- 00844735006384
- Version / Model
- 529500001061
- Catalog Number
- GEM1500
- Company Name
- SYNOVIS MICRO COMPANIES ALLIANCE, INC
- Labeler DUNS
- 031284586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-04
- Public Version
- 1
- Public Version Date
- 2025-03-12
- Public Version Status
- New
- Public Device Record Key
- 0ff69fca-d813-44e7-be5e-566f7172ec08
Device Description
Automatic Microclip Applier
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
- 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 |
|---|---|---|---|---|---|---|
| Package | 10844735006381 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00844735006384 | GS1 |
Customer Contacts
- Phone
- +1(800)510-3318
- [email protected]