AMT MiniSPC Drainage Set ES1-1221, S1-1221

GUDID 00842071148348

12" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Suprapubic drainage catheter
Primary Device ID00842071148348
NIH Device Record Keyba1c14a4-00be-4eea-95b3-a52148cab5cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT MiniSPC Drainage Set
Version Model NumberES1-1221
Catalog NumberES1-1221, S1-1221
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net

Device Dimensions

Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch
Length12 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071148331 [Primary]
GS100842071148348 [Package]
Contains: 00842071148331
Package: Box (S1-1221) [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOBCatheter, Suprapubic (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-03
Device Publish Date2025-01-24

On-Brand Devices [AMT MiniSPC Drainage Set]

0084207114836224" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched)
0084207114834812" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.