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Easygrip Flo-41

FDA UDI

Class II (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name
EASYGRIP FLO-41 FDA UDI
Generic Name
Haematological concentrate/haemostatic agent applicator FDA UDI
Device Name
The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe. FDA UDI
Model / Reference
ADS201897 FDA UDI
Description
The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe. FDA UDI

Identifiers

Catalog Number
ADS201897 FDA UDI
Primary DI / UDI-DI
05413765586118 FDA UDI
510(k) Number
K193137 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Haematological concentrate/haemostatic agent applicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

Yes

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

Dimensions & Sizes

Size
Length — 41 Centimeter FDA UDI

Category: Haematological concentrate/haemostatic agent applicator

Easygrip Flo-41 by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematological concentrate/haemostatic agent applicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA UDI 51a80c6a-390c-4bb1-affd-7de4c2d5b4b0 38 fields · synced May 30, 2026