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Symmetry

FDA UDI

Class II (US FDA UDI)

by Symmetry Surgical Inc.

Identity

Trade Name
Symmetry FDA UDI
Generic Name
Surgical sleeve cover FDA UDI
Device Name
Symmetry® Sheath, 5 mm Diameter, w/Flushport, 450 mm FDA UDI
Model / Reference
90-1115L FDA UDI
Description
Symmetry® Sheath, 5 mm Diameter, w/Flushport, 450 mm FDA UDI

Identifiers

Catalog Number
90-1115L FDA UDI
Primary DI / UDI-DI
00887482129340 FDA UDI
510(k) Number
K974382 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Surgical sleeve cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 450 Millimeter FDA UDI

Category: Surgical sleeve cover

Symmetry by Symmetry Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical sleeve cover.

Cleared under the same submission

K974382 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Symmetry Surgical Inc.

Sources (1)

  • FDA UDI 7dd09059-7bce-4d58-b1c6-53afde3610ee 37 fields · synced May 31, 2026