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Djo Surgical

FDA UDI

Class I (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name
DJO SURGICAL FDA UDI
Generic Name
Manual surgical saw blade, flexible, reusable FDA UDI
Device Name
SAW CAPTURE, .050 BLADE, TYPE 2, EXTERNAL FDA UDI
Model / Reference
801-01-170 FDA UDI
Description
SAW CAPTURE, .050 BLADE, TYPE 2, EXTERNAL FDA UDI

Identifiers

Primary DI / UDI-DI
00888912127745 FDA UDI
FDA Product Code
GFA FDA UDI
GMDN Term
Manual surgical saw blade, flexible, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Manual surgical saw blade, flexible, reusable

Djo Surgical by Encore Medical, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual surgical saw blade, flexible, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Encore Medical, L.p.

Sources (1)

  • FDA UDI 437880c3-ef15-4b2e-a2e7-6e49edc5bda2 33 fields · synced May 30, 2026