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Smartstitch Perfectpasser

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
SMARTSTITCH PERFECTPASSER FDA UDI
Generic Name
Arthroscopic suturing unit FDA UDI
Device Name
SMARTSTITCH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGES, WHITE FDA UDI
Model / Reference
OM-8175 FDA UDI
Description
SMARTSTITCH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGES, WHITE FDA UDI

Identifiers

Catalog Number
OM-8175 FDA UDI
Primary DI / UDI-DI
00817470005806 FDA UDI
510(k) Number
K123268 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Arthroscopic suturing unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Arthroscopic suturing unit

Smartstitch Perfectpasser by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic suturing unit.

Cleared under the same submission

K123268 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI ea9539b5-bd5d-4389-93e1-1059954e8fef 36 fields · synced Jun 8, 2026