FDA UDI
In Commercial Distribution
🇺🇸 United States
OsteoCentric Headless Compression System Feilchenfeld Forceps 3 1/2 inch
DI: 00850015496431
·
Model: EX01-0050
·
Osteocentric Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OsteoCentric Headless Compression System Feilchenfeld Forceps 3 1/2 inch
- Primary DI
- 00850015496431
- Version / Model
- EX01-0050
- Catalog Number
- EX01-0050
- Company Name
- Osteocentric Technologies, Inc.
- Labeler DUNS
- 089645059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-15
- Public Version
- 2
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- 1eb079c9-200b-4a46-bef1-5b858d9078de
Device Description
Headless Compression System Feilchenfeld Forceps 3 1/2 inch
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
- No
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62466 | Surgical soft-tissue manipulation forceps, tweezers-like, reusable | A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850015496431 | GS1 |
Customer Contacts
- Phone
- 1 800-969-0639
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200259 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.5 | Inch |