Surgilube

FDA UDI

Class I (US FDA UDI)

by H R Pharmaceuticals, Inc.

Identity

Trade Name: Surgilube FDA UDI
Generic Name: General-body orifice lubricant FDA UDI
Device Name: Sterile Surgical Lubricant, Tube FDA UDI
Model / Reference: 281020537 FDA UDI
Description: Sterile Surgical Lubricant, Tube FDA UDI

Identifiers

Catalog Number: 281020537 FDA UDI
Primary DI / UDI-DI: 00851809002456 FDA UDI
FDA Product Code: KMJ FDA UDI
GMDN Term: General-body orifice lubricant FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6375 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Dimensions & Sizes

Size: Weight — 120.49 Gram FDA UDI

Category: General-body orifice lubricant Multi-purpose surgical instrument lubricant

Surgilube by H R Pharmaceuticals, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose surgical instrument lubricant.

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Surgilube — H R Pharmaceuticals, Inc. · Class I
Surgilube — H R Pharmaceuticals, Inc. · Class I
Surgilube — H R Pharmaceuticals, Inc. · Class I
Surgilube — H R Pharmaceuticals, 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: H R Pharmaceuticals, Inc.

Sources (1)

FDA UDI 4038d600-f3f8-4aa5-853a-7c55c3bdf17e 37 fields · synced May 31, 2026