Identity
- Trade Name
- Disposable Kit, Sterile (S) FDA UDI
- Generic Name
- Hair extraction punch FDA UDI
- Model / Reference
- 19G 2 Prong FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850470007425 FDA UDI
- 510(k) Number
- K103428 FDA UDI
- FDA Product Code
- ONA FDA UDI
- GMDN Term
- Hair extraction punch FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hair extraction punch
Disposable Kit, Sterile (S) by Restoration Robotics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hair extraction punch.
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Cleared under the same submission
K103428 also covers:
- Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile — RESTORATION ROBOTICS, INC.
- Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile — RESTORATION ROBOTICS, INC.
- Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile — RESTORATION ROBOTICS, INC.
- Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile — RESTORATION ROBOTICS, INC.
- Disposable Kit, Sterile (S) — RESTORATION ROBOTICS, INC.
- Disposable Kit, Sterile (S) — RESTORATION ROBOTICS, INC.
- Disposable Kit, Sterile (S) — RESTORATION ROBOTICS, INC.
- Disposable Kit, Sterile (S) — RESTORATION ROBOTICS, INC.
- Disposable Kit, Sterile (S) — RESTORATION ROBOTICS, INC.
- Disposable Kits, Sterile and Non-Sterile (S) — RESTORATION ROBOTICS, INC.
- Disposable Kits, Sterile and Non-Sterile (S) — RESTORATION ROBOTICS, INC.
- Disposable Kits, Sterile and Non-Sterile (S) — RESTORATION ROBOTICS, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Restoration Robotics, Inc.
Sources (1)
- FDA UDI 406857db-155a-49a8-981e-c11ab45d3118 33 fields · synced May 30, 2026