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Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Manual surgical saw blade, flexible, single-use FDA UDI
Device Name
Gigli Saw Handle Pair FDA UDI
Model / Reference
SD922120100 FDA UDI
Description
Gigli Saw Handle Pair FDA UDI

Identifiers

Catalog Number
SD922120100 FDA UDI
Primary DI / UDI-DI
B382SD9221201000 FDA UDI
FDA Product Code
EIG FDA UDI
GMDN Term
Manual surgical saw blade, flexible, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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, single-use

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

Similar devices

Also classified as Manual surgical saw blade, flexible, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Direct, Inc.

Sources (1)

  • FDA UDI 49b0e142-ddbe-4780-9644-fcaa51f3a71a 35 fields · synced Jun 8, 2026