Super XL Enema System 901203

GUDID 10815112021563

SXL w/Att. (Silicone Cuff)

Bracco Diagnostics Inc.

Barium enema catheter
Primary Device ID10815112021563
NIH Device Record Keydd1f4c7b-d275-486a-9bba-67810dbdb9f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper XL Enema System
Version Model Number901203
Catalog Number901203
Company DUNS849234661
Company NameBracco Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-524-2873
Emailxx@xx.xx
Phone609-524-2873
Emailxx@xx.xx
Phone609-524-2873
Emailxx@xx.xx
Phone609-524-2873
Emailxx@xx.xx

Device Dimensions

Catheter Gauge48 French
Catheter Gauge48 French
Catheter Gauge48 French
Catheter Gauge48 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112021563 [Primary]
GS130815112021567 [Package]
Package: [24 Units]
In Commercial Distribution

FDA Product Code

FGDCatheter, Retention, Barium Enema With Bag

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-30

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10815112021563 - Super XL Enema System2025-06-09SXL w/Att. (Silicone Cuff)
10815112021563 - Super XL Enema System2025-06-09 SXL w/Att. (Silicone Cuff)
30815112021581 - Enema Kit: Empty Enema Bag Delivery System2025-06-09 Empty Snap Cap Bag
10815112021594 - EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System2025-06-09 Empty Exacta l Bag
10815112021624 - 24 Fr Infant Flexi Tip: Pediatric Enema Tip2025-06-09 Infant Flexi Tip
30815112021635 - Miller Enema Air Tip: Without Retention Cuff2025-06-09 Miller Air Tip
00815112021641 - 14 French Pediatric Flexi Tip2025-06-09 14 Fr Pediatric Flexi Tip

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