FDA UDI
In Commercial Distribution
🇺🇸 United States
PROstep™ TBC
DI: 00889797100069
·
Model: 97700011
·
WRIGHT MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROstep™ TBC
- Primary DI
- 00889797100069
- Version / Model
- 97700011
- Catalog Number
- 97700011
- Company Name
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 807201207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-24
- Public Version
- 2
- Public Version Date
- 2022-08-12
- Public Version Status
- Update
- Public Device Record Key
- fc3e260c-5015-47d1-a62d-8f20388c7ac0
Device Description
Broach
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
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTQ | BROACH | 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 | 00889797100069 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7117
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large |