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Stratafix Spiral

FDA UDI

Class II (US FDA UDI)

by Surgical Specialties México, S. de R.L. de C.V.

Identity

Trade Name
Stratafix Spiral FDA UDI
Generic Name
Barbed polyester suture, non-antimicrobial FDA UDI
Device Name
2FS 2-0 UNDYD MONODERM 14X14 FDA UDI
Model / Reference
SXMD2B411 FDA UDI
Description
2FS 2-0 UNDYD MONODERM 14X14 FDA UDI

Identifiers

Primary DI / UDI-DI
10705031208070 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Barbed polyester suture, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Barbed polyester suture, non-antimicrobial

Stratafix Spiral by Surgical Specialties México, S. de R.L. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Barbed polyester suture, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Specialties México, S. de R.L. de C.V.

Sources (1)

  • FDA UDI 9e53b112-85d0-423c-9d15-5adccf374b1a 35 fields · synced Jun 6, 2026