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3/4 inch Cobb

FDA UDI

Class II (US FDA UDI)

by Surgentec Llc

Identity

Trade Name
3/4 inch Cobb FDA UDI
Generic Name
Bone file/rasp, manual, single-use FDA UDI
Model / Reference
SR10-5010 FDA UDI

Identifiers

Primary DI / UDI-DI
00858406007716 FDA UDI
510(k) Number
K200431 FDA UDI
FDA Product Code
FMF FDA UDI
HTR FDA UDI
GMDN Term
Bone file/rasp, manual, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
878.4800 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone file/rasp, manual, single-use

3/4 inch Cobb by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone file/rasp, manual, single-use.

Cleared under the same submission

K200431 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgentec Llc

Sources (1)

  • FDA UDI 94f48930-37c2-4efd-a0d6-0d0e42b0aeeb 33 fields · synced May 30, 2026