FDA UDI
In Commercial Distribution
🇺🇸 United States
DIGITALIS INSTRUMENTS
DI: 08057717559941
·
Model: Digitalis PIP Rasp
·
BRM EXTREMITIES SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DIGITALIS INSTRUMENTS
- Primary DI
- 08057717559941
- Version / Model
- Digitalis PIP Rasp
- Catalog Number
- DDGI202002
- Company Name
- BRM EXTREMITIES SRL
- Labeler DUNS
- 435126746
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-03
- Public Version
- 1
- Public Version Date
- 2024-04-11
- Public Version Status
- New
- Public Device Record Key
- bf196da0-7372-4a61-8f6f-bba00c492c5c
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36167 | Orthopaedic broach | A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057717559941 | GS1 |
Customer Contacts
- Phone
- +3903411693087
- [email protected]
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.