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Maxima

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Maxima FDA UDI
Generic Name
Polytetrafluoroethylene suture FDA UDI
Device Name
Maxima Suture PTFE FS-2 19mm FDA UDI
Model / Reference
1127253 FDA UDI
Description
Maxima Suture PTFE FS-2 19mm FDA UDI

Identifiers

Catalog Number
1127253 FDA UDI
Primary DI / UDI-DI
10304040001223 FDA UDI
FDA Product Code
NBY FDA UDI
GMDN Term
Polytetrafluoroethylene suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5035 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Polytetrafluoroethylene suture

Maxima by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polytetrafluoroethylene suture.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 623b0df3-1789-4f92-8cdb-777713800a21 34 fields · synced Jun 1, 2026