Safe N Simple SNS7612298

GUDID 00810040133725

12" Drainable One Piece Pouch Extended Wear Convex Transparent 1 1/8" Pre Cut Stoma Opening with standard curved tail closure and Belt Tabs

SAFE N' SIMPLE LLC

One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended One-piece intestinal ostomy bag, open-ended
Primary Device ID00810040133725
NIH Device Record Keyc4e1d8df-2fc2-4390-aac0-152b3052e96b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafe N Simple
Version Model NumberSNS7612298
Catalog NumberSNS7612298
Company DUNS807812412
Company NameSAFE N' SIMPLE LLC
Device Count80
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com
Phone248 214 4877
Emailamy@sns-medical.com

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
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
GS100810040133725 [Unit of Use]
GS100810040133732 [Primary]
GS100810040133749 [Primary]

FDA Product Code

EZSAppliance, Colostomy, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-09
Device Publish Date2023-11-01