FDA UDI
In Commercial Distribution
🇺🇸 United States
RAPTORMITE / ULTRABRAID
DI: 03596010001887
·
Model: 72201805
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RAPTORMITE / ULTRABRAID
- Primary DI
- 03596010001887
- Version / Model
- 72201805
- Catalog Number
- 72201805
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-10
- Public Version
- 6
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- ec0dc7cb-634e-4f62-ab91-d8f646223271
Device Description
RAPTORMITE 3.7 AB W/NDL 20 ULTRABRAID
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010001887 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151105 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 140 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius