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Reprocessed Sagittal Saw Blade, Small Bone, 25.4 x 9.5 x 0.63mm

FDA UDI

Class I (US FDA UDI)

by Suretek Medical

Identity

Trade Name
Reprocessed Sagittal Saw Blade, Small Bone, 25.4 x 9.5 x 0.63mm FDA UDI
Generic Name
Surgical power tool system handpiece, sawing, line-powered FDA UDI
Model / Reference
KM-3101 FDA UDI

Identifiers

Primary DI / UDI-DI
B390KM31011 FDA UDI
FDA Product Code
GFA FDA UDI
GMDN Term
Surgical power tool system handpiece, sawing, line-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical power tool system handpiece, sawing, line-powered

Reprocessed Sagittal Saw Blade, Small Bone, 25.4 x 9.5 x 0.63mm by Suretek Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool system handpiece, sawing, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suretek Medical

Sources (1)

  • FDA UDI 4c064a21-1a9d-4fb4-96c9-1bad1f5feeaf 32 fields · synced May 31, 2026