Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINE FDA UDI
Generic Name: Bone file/rasp, reciprocating, single-use FDA UDI
Device Name: KM-802 RASP,CROSS HATCH,SST 11.5MM X FDA UDI
Model / Reference: KM802RH FDA UDI
Description: KM-802 RASP,CROSS HATCH,SST 11.5MM X FDA UDI

Identifiers

Catalog Number: KM802RH FDA UDI
Primary DI / UDI-DI: 10888277377011 FDA UDI
FDA Product Code: GAC FDA UDI
GMDN Term: Bone file/rasp, reciprocating, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

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

Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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BONE FILE #64X CROSS CUT HD D/E — W.H. Holden, Inc. · Class I
BONE FILE #52X CROSS CUT HF D/E — W.H. Holden, Inc. · Class I
BONE FILE #52X CROSS CUT HD D/E — W.H. Holden, Inc. · Class I
BONE FILE WAHL 1W SINGLE CUT HD D/E — W.H. Holden, Inc. · Class I
MicroAire® — MicroAire Surgical Instruments LLC · Class I
MicroAire® — MicroAire Surgical Instruments LLC · Class I
BONE FILE #21X CROSS CUT HD D/E — W.H. Holden, Inc. · Class I

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: Medline Industries, Inc.

Sources (1)

FDA UDI 41fff8ee-7040-49ca-ae8c-d38639b68be9 35 fields · synced May 30, 2026