FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 20886982077742
·
Model: 03.306.011
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- NA
- Primary DI
- 20886982077742
- Version / Model
- 03.306.011
- Catalog Number
- 03306011
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 4
- Public Version Date
- 2022-05-02
- Public Version Status
- Update
- Public Device Record Key
- 58d3b0cb-d142-4f96-b236-690452d44cd6
Device Description
8MM PROTECTIVE CAP
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
- 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 |
|---|---|---|---|---|
| JEC | COMPONENT, TRACTION, INVASIVE | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47873 | Pelvic C-clamp | A manual surgical instrument designed as an emergency stabilization device for unstable injuries and fractures of the pelvic ring; these conditions can be associated with massive blood loss and terminal shock. It is mechanically fixed to either side of the pelvis by means of thick nails permitting quick and efficient compression and stabilization of pelvic fractures and luxations providing time for haemorrhage and embolization control. It is typically designed as a C-shaped frame with a rail, twin adjustable arms, adjusting side screws, and nails made of high-grade stainless steel and/or synthetic material. It is compatible for use in computed tomography (CT). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H679033060110 | HIBCC | ||||
| Primary | 20886982077742 | GS1 | ||||
| Unit of Use | 80886982077744 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071476 | 000 |