FDA UDI
In Commercial Distribution
🇺🇸 United States
HALLU-FIX
DI: 10381780043409
·
Model: 117160SND
·
NEWDEAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HALLU-FIX
- Primary DI
- 10381780043409
- Version / Model
- 117160SND
- Catalog Number
- 117160SND
- Company Name
- NEWDEAL
- Labeler DUNS
- 536935331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-09
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- a1adbeb2-b298-4aba-bfef-b4a4e15af214
- Distribution End Date
- 2027-12-31
Device Description
The sterile HALLU-S plates are available in different sizes (left/right). They are both low profile titanium alloy plates dedicated to the first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation and they are contoured for optimal bone coverage. They are implanted using SNAP-OFF screws which exist in different diameters and sizes.
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
- 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
- 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 |
|---|---|---|---|---|
| HRS | PLATE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46647 | Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780043409 | GS1 | ||||
| Secondary | M248117160SND1 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093781 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 55mm length x 19mm width |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place.