Sterion®Suture Aid Booties

FDA UDI

Class I (US FDA UDI)

by Aspen Surgical Products, Inc.

Identity

Trade Name: Sterion®Suture Aid Booties FDA UDI
Generic Name: Vascular booties FDA UDI
Device Name: Intended used to protect, tag and help located sutures during surgery FDA UDI
Model / Reference: 052003BBG FDA UDI
Description: Intended used to protect, tag and help located sutures during surgery FDA UDI

Identifiers

Primary DI / UDI-DI: 00840113227617 FDA UDI
FDA Product Code: KDC FDA UDI
GMDN Term: Vascular booties 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vascular booties

Sterion®Suture Aid Booties by Aspen Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular booties.

Sterile protective cover N°163 DE1 — ARMOR d.o.o. AZANJA · Class I
TIP COVERS — SONTEC INSTRUMENTS, INC. · Class I
Dome Bag — Exact Medical Manufacturing, Inc · Class I
STERINORM® Bodennaht-Beutel — Udo Heisig GmbH The Disposables Company · Class I
STERINORM® Spangenbezug C-SET — Udo Heisig GmbH The Disposables Company · Class I
NP180 — SUZHOU DUKANGNING MEDICAL PRODUCTS CO., LTD · Class I
Positioning pillow protective cover — Cobes Industries(Hefei) Co.,Ltd · Class I
Scanlan® SURG-I-PAW® Instrument Covers — SCANLAN INTERNATIONAL 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Aspen Surgical Products, Inc.

Sources (1)

FDA UDI 886dc80d-74b3-48b6-84bf-c33124927325 34 fields · synced Jun 9, 2026