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XL Flexi Tip: Adult Enema Tip

FDA UDI

Class II (US FDA UDI)

by Bracco Diagnostics Inc.

Identity

Trade Name
XL Flexi Tip: Adult Enema Tip FDA UDI
Generic Name
Enema tip, single-use FDA UDI
Device Name
XL Flexi Tip FDA UDI
Model / Reference
901302 FDA UDI
Description
XL Flexi Tip FDA UDI

Identifiers

Catalog Number
901302 FDA UDI
Primary DI / UDI-DI
10815112021006 FDA UDI
FDA Product Code
FGD FDA UDI
GMDN Term
Enema tip, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Enema tip, single-use

XL Flexi Tip: Adult Enema Tip by Bracco Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enema tip, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bracco Diagnostics Inc.

Sources (1)

  • FDA UDI fe2b26bd-372b-4037-99b9-d92ddd30e775 35 fields · synced Jun 1, 2026