SURFIX
- Primary DI
- M248SP040ND1
- Brand
- SURFIX
- Company
- NEWDEAL
- Model
- SP040ND
- Catalog number
- SP040ND
- Device description
- SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 20 mm to 100 mm.
- Published
- 2017-10-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
integralife.comProduct Codes#
| Code | Name |
|---|---|
| HRS | PLATE, FIXATION, BONE |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K041601 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780051244 | Primary | GS1 | 0 | |
| M248SP040ND1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780051244 | 10381780051244 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone screw, non-bioabsorbable, sterile | A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Must be stored in a dry, cool place away from dust and UV radiation |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 536935331
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780045687 | K-WIRE | 115071ND | 115071ND | 2017-10-09 |
| 10381780045731 | K-WIRE | 115110ND | 115110ND | 2017-10-09 |
| 10381780045755 | K-WIRE | 115111ND | 115111ND | 2017-10-09 |
| 10381780045786 | K-WIRE | 115170ND | 115170ND | 2017-10-09 |
| 10381780045809 | K-WIRE | 115171ND | 115171ND | 2017-10-09 |
| 10381780045847 | K-WIRE | 115316ND | 115316ND | 2017-10-09 |
| 10381780045854 | K-WIRE | 115416ND | 115416ND | 2017-10-09 |
| 10381780041771 | QWIX® | 119932ND | 2017-05-26 | |
| 10381780042099 | Hallu®-FIX | 129930ND | 2017-05-26 | |
| 10381780042136 | Hallu®-FIX | 129935ND | 2017-05-26 | |
| 10381780042266 | ADVANSYS® | 169101ND | 2017-05-26 | |
| 10381780042273 | ADVANSYS® | 169102ND | 2017-05-26 | |
| 10381780042280 | ADVANSYS® | 169104ND | 2017-05-26 | |
| 10381780042327 | ADVANSYS® | 188201ND | 2017-05-26 | |
| 10381780042334 | ADVANSYS® | 188202ND | 2017-05-26 | |
| 10381780042419 | IPP-ON® | 239000ND | 2017-05-26 | |
| 10381780042426 | IPP-ON® | 239001ND | 2017-05-26 | |
| 10381780042778 | PANTA® | 519920ND | 2017-05-26 | |
| 10381780042822 | SURFIX® | SET000ND | 2017-05-26 | |
| 10381780042839 | SURFIX® | SET100ND | 2017-05-26 |
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