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Simple Gap Block, Straight

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name
Simple Gap Block, Straight FDA UDI
Generic Name
Orthopaedic knee-balance analyser, non-electrical FDA UDI
Device Name
Simple Gap Block, Straight, Size 2, 14-16mm thickness FDA UDI
Model / Reference
2222.02.014 FDA UDI
Description
Simple Gap Block, Straight, Size 2, 14-16mm thickness FDA UDI

Identifiers

Primary DI / UDI-DI
00819251026529 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic knee-balance analyser, non-electrical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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: Orthopaedic knee-balance analyser, non-electrical

Simple Gap Block, Straight by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic knee-balance analyser, non-electrical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Total Joint Orthopedics, Inc.

Sources (1)

  • FDA UDI 9a6be107-2c73-46c2-a2f5-86e5e7f32b73 36 fields · synced May 31, 2026