FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00841379101239
·
Model: BZ0300004
·
HYHTE HOLDINGS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00841379101239
- Version / Model
- BZ0300004
- Catalog Number
- BZ0300004
- Company Name
- HYHTE HOLDINGS, INC.
- Labeler DUNS
- 073029645
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-29
- Public Version
- 1
- Public Version Date
- 2022-09-06
- Public Version Status
- New
- Public Device Record Key
- c296ce94-fc8a-40c4-8db6-2f213a3fbb49
Device Description
PADDLE DISTRACTOR
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 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62787 | Orthopaedic surgical distractor, external | A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841379101239 | GS1 |
Customer Contacts
- Phone
- 7608148047
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4 | Millimeter |