FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00841379185703
·
Model: GZB040020
·
HYHTE HOLDINGS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00841379185703
- Version / Model
- GZB040020
- Catalog Number
- GZB040020
- Company Name
- HYHTE HOLDINGS, INC.
- Labeler DUNS
- 073029645
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-16
- Public Version
- 1
- Public Version Date
- 2021-07-26
- Public Version Status
- New
- Public Device Record Key
- ade5566e-78bf-4644-bd98-e4707084c955
Device Description
LLIF PENFIELD PULL
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 |
|---|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | 888.3080 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47853 | Intravascular ultrasound imaging catheter extractor, reusable | A non-sterile, battery-powered, electronic device intended to slowly retract (pull back) an intravascular ultrasound imaging catheter from a coronary or peripheral artery at a controlled rate using a motor combined with an extraction mechanism. This device is used in the catheterization laboratory during intravascular assessment, e.g., for the reconstruction of a two dimensional, sagittal ultrasonic diagnostic image as the catheter is slowly extracted. Pullback lengths are around 13 cm. This device is not sterilizable and must therefore be enclosed in a sterile barrier (a bag or pouch). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841379185703 | GS1 |
Customer Contacts
- Phone
- 7608148047
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Millimeter |