Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- SEMB PERIOSTEAL RASPATORY FIG. 1 LENGTH 170 MM FDA UDI
- Model / Reference
- KN.1453.01 FDA UDI
- Description
- SEMB PERIOSTEAL RASPATORY FIG. 1 LENGTH 170 MM FDA UDI
Identifiers
- Catalog Number
- KN.1453.01 FDA UDI
- Primary DI / UDI-DI
- 04049047061328 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone file/rasp, manual, reusable
A comprehensive medical device directory entry for Gimmi, an orthopedic manual surgical instrument designed to provide precise bone scraping and smoothing during surgical procedures. This device is made of metal (stainless steel or titanium) and features a surface with coarse and/or fine grooves or teeth.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (1)
- FDA UDI 199a778b-15e2-4248-8cdd-7864d545407a 35 fields · synced Jul 17, 2026