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Mediflex Laparoscopic Instruments - Needle Holders

FDA UDI

Class I (US FDA UDI)

by Flexbar Machine Corp.

Identity

Trade Name
Mediflex Laparoscopic Instruments - Needle Holders FDA UDI
Generic Name
Externally-anchored laparoscopic retractor FDA UDI
Device Name
Modular Needle Holder w/ Radel Handle, 5mm x 26cm, Jaw CVS Right FDA UDI
Model / Reference
92023-26 FDA UDI
Description
Modular Needle Holder w/ Radel Handle, 5mm x 26cm, Jaw CVS Right FDA UDI

Identifiers

Primary DI / UDI-DI
00842102112218 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Externally-anchored laparoscopic retractor 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: Externally-anchored laparoscopic retractor

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

Similar devices

Also classified as Externally-anchored laparoscopic retractor.

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 0a17b535-bbf5-41ea-990e-f143c5ab9fd5 33 fields · synced Jun 1, 2026