FDA UDI
In Commercial Distribution
🇺🇸 United States
Taperloc
DI: 00889024516595
·
Model: SSI003222
·
Zimmer, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Taperloc
- Primary DI
- 00889024516595
- Version / Model
- SSI003222
- Catalog Number
- SSI003222
- Company Name
- Zimmer, Inc.
- Labeler DUNS
- 056038268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-28
- Public Version
- 1
- Public Version Date
- 2018-09-28
- Public Version Status
- New
- Public Device Record Key
- 31bad1fc-24a0-46c7-8785-4d78fb69c18c
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HWB | Extractor | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44597 | Orthopaedic cement extractor, manual | A hand-held manual surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application during an orthopaedic surgical procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other manually-operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024516595 | GS1 |
Customer Contacts
- Phone
- 1 (800) 343-9500
- [email protected]