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Mediflex Laparoscopic Instruments - Suture Grasper Guides

FDA UDI

Class I (US FDA UDI)

by Flexbar Machine Corp.

Identity

Trade Name
Mediflex Laparoscopic Instruments - Suture Grasper Guides FDA UDI
Generic Name
Suturing guide FDA UDI
Device Name
Suture Passer Guide, 10mm x 11.2cm FDA UDI
Model / Reference
94415 FDA UDI
Description
Suture Passer Guide, 10mm x 11.2cm FDA UDI

Identifiers

Primary DI / UDI-DI
00842102112331 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Suturing guide 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

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

Category: Suturing guide

Mediflex Laparoscopic Instruments - Suture Grasper Guides by Flexbar Machine Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suturing guide.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flexbar Machine Corp.

Sources (1)

  • FDA UDI a68d8efe-0a82-49be-b100-432381c277a1 33 fields · synced May 29, 2026