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Lead Loop

FDA UDI

Class II (US FDA UDI)

by Suture Concepts Inc.

Identity

Trade Name
Lead Loop FDA UDI
Generic Name
Neural-tissue electrical stimulation lead adaptor FDA UDI
Device Name
Suture Concepts Lead Loop Suturing Device FDA UDI
Model / Reference
CAT-LLSD11 FDA UDI
Description
Suture Concepts Lead Loop Suturing Device FDA UDI

Identifiers

Catalog Number
CAT-LLSD11 FDA UDI
Primary DI / UDI-DI
M759LLSD10 FDA UDI
510(k) Number
K150924 FDA UDI
FDA Product Code
GZB FDA UDI
GMDN Term
Neural-tissue electrical stimulation lead adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Safe FDA UDI

Category: Neural-tissue electrical stimulation lead adaptor

Lead Loop by Suture Concepts Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neural-tissue electrical stimulation lead adaptor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suture Concepts Inc.

Sources (1)

  • FDA UDI c81a08a1-84d5-4e0a-9417-57b2d227dcbf 36 fields · synced Jun 8, 2026