FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOTRONIK
DI: 04035479170271
·
Model: SCS Anchor
·
BIOTRONIK SE & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- BIOTRONIK
- Primary DI
- 04035479170271
- Version / Model
- SCS Anchor
- Catalog Number
- 457858
- Company Name
- BIOTRONIK SE & Co. KG
- Labeler DUNS
- 315620229
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-04-06
- Public Version
- 1
- Public Version Date
- 2023-04-14
- Public Version Status
- New
- Public Device Record Key
- eda0bc74-93e0-4d2c-9bab-b4b25f98a23c
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| LGW | Stimulator, spinal-cord, totally implanted for pain relief | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45612 | Soft-tissue/mesh anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04035479184322 | GS1 | ||||
| Primary | 04035479170271 | GS1 |
Customer Contacts
- Phone
- +1(888)345-0374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210037 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit