Scanlan® SURG-I-LOOP® silicone loops

FDA UDI

Class I (US FDA UDI)

by Scanlan International Inc

Identity

Trade Name: Scanlan® SURG-I-LOOP® silicone loops FDA UDI
Generic Name: Surgical vessel loop FDA UDI
Device Name: Scanlan® SURG-I-LOOP® silicone loops - White Maxi, 2.5x1.02 mm, 16"/40 cm long, Bulk Non-Sterile (20/pkg) FDA UDI
Model / Reference: 1001-82B FDA UDI
Description: Scanlan® SURG-I-LOOP® silicone loops - White Maxi, 2.5x1.02 mm, 16"/40 cm long, Bulk Non-Sterile (20/pkg) FDA UDI

Identifiers

Catalog Number: 1001-82B FDA UDI
Primary DI / UDI-DI: 00846159027808 FDA UDI
FDA Product Code: GAE FDA UDI
GMDN Term: Surgical vessel loop FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Ethylene Oxide FDA UDI

Category: Surgical vessel loop

Scanlan® SURG-I-LOOP® silicone loops by Scanlan International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical vessel loop.

Key Surgical Vascular Loops — Key Surgical, LLC · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
Devon — Cardinal Health 200, LLC · Class I
Degania — DEGANIA SILICONE LTD · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II

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: Scanlan International Inc

Sources (1)

FDA UDI c96e96fd-fa9b-4d12-a056-f7b855b7f9ad 35 fields · synced Jun 8, 2026