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Disposable Sterile Kit

FDA UDI

Class II (US FDA UDI)

by Restoration Robotics, Inc.

Identity

Trade Name
Disposable Sterile Kit FDA UDI
Generic Name
Hair extraction punch FDA UDI
Model / Reference
18G 2 Prong 6mm Punch FDA UDI

Identifiers

Catalog Number
FP-100054 FDA UDI
Primary DI / UDI-DI
00850470007173 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

No

FDA UDI

Category: Hair extraction punch

Disposable Sterile Kit by Restoration Robotics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hair extraction punch.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 75479abb-96c4-4d47-b3cc-41a0d4456fba 33 fields · synced May 30, 2026