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Double-Ended Paddle Retractor

FDA UDI

Class I (US FDA UDI)

by Medshape, Inc.

Identity

Trade Name
Double-Ended Paddle Retractor FDA UDI
Generic Name
Hand-held surgical retractor, single-use FDA UDI
Model / Reference
3400-18-000 FDA UDI

Identifiers

Primary DI / UDI-DI
M9703400180000 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Hand-held surgical retractor, single-use 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

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: Hand-held surgical retractor, single-use

Double-Ended Paddle Retractor by Medshape, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held surgical retractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medshape, Inc.

Sources (1)

  • FDA UDI dbe49bca-8af7-4a00-9077-71882b5f5852 32 fields · synced May 30, 2026