FDA UDI
In Commercial Distribution
🇺🇸 United States
Silktoe Spacer
DI: 08057717550832
·
Model: SIZE 30 RIGHT
·
BRM EXTREMITIES SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Silktoe Spacer
- Primary DI
- 08057717550832
- Version / Model
- SIZE 30 RIGHT
- Catalog Number
- BRDNEWP3030R
- Company Name
- BRM EXTREMITIES SRL
- Labeler DUNS
- 435126746
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-17
- Public Version
- 1
- Public Version Date
- 2021-10-25
- Public Version Status
- New
- Public Device Record Key
- 11a5912a-9992-4fdd-b979-663ff1ac5391
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
- 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 |
|---|---|---|---|---|
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | 888.3720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33700 | Total metatarsophalangeal joint prosthesis, one-piece | An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057717550832 | GS1 |
Customer Contacts
- Phone
- +3903411693087
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191966 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 30 RIGHT |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature, keep dry and away from humidity and direct sources of light and heat