FDA.reportPublic FDA data

Safe N Simple

Primary DI
00810040133909
Brand
Safe N Simple
Company
SAFE N' SIMPLE LLC
Model
SNS7814214
Catalog number
SNS7814214
Device description
5" Diameter 2-Piece Round Wafer Extended Wear with Solid Hydrocolloid 57mm 2 1/4" Flange Cut to Fit
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZSAppliance, Colostomy, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZSAppliance, Colostomy, DisposableGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040133916PrimaryGS10
00810040133923PrimaryGS10
00810040133909Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040133916008100401339168100401339160810040133916
00810040133923008100401339238100401339230810040133923
00810040133909008100401339098100401339090810040133909

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy base plate, flatA non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2482144877amy@sns-medical.com

Regulatory Flags#

DUNS number
807812412
Device count
40
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00008140135941SimpuritySNS52245SNS522452026-02-10
10810040131872SimpuritySNS52277SNS522772025-06-17
10810040135955SimpuritySNS52245SNS522452025-06-17
20810040131879SimpuritySNS52277SNS522772025-06-17
00810040135699SimpuritySNS51222SNS512222025-06-17
00810040135705SimpuritySNS51222SNS512222025-06-17
00810040135712SimpuritySNS51244SNS512442025-06-17
00810040135729SimpuritySNS51244SNS512442025-06-17
00810040135958SimpuritySNS52245SNS522452025-06-17
00854261007564SimpuritySNS51222SNS512222025-06-17
00854261007571SimpuritySNS51244SNS512442025-06-17
00810040135941SimpuritySNS52245SNS522452025-06-17
00810040131875SimpuritySNS52277SNS522772025-06-17
00850004779798SimpuritySNS52222SNS522222021-11-30
00854261007588SimpuritySNS52244SNS522442021-11-30
00896005002428SimpuritySNS50002SNS500022021-11-30
00850004779286SimpuritySNS52244SNS522442019-08-12
00850004779743SimpuritySNS50002SNS500022019-08-12
00850004779804SimpuritySNS52222SNS522222019-08-12
10810040131896SimpuritySNS52377SNS523772025-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10661613525006UltraMaxMarlen Manufacturing And Development Co.EZS2026-04-28
30885632431160HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431207HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431214HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431245HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431163HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431200HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431217HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431248HalyardO&M HALYARD, INC.EZS2025-01-10
00860010269800OstohOstoh, LLCEZS2024-12-16
10885632431128HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431135HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431142HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431159HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431227HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431234HalyardO&M HALYARD, INC.EZS2024-11-12
10885632434709HalyardO&M HALYARD, INC.EZS2024-11-12
10885632434716HalyardO&M HALYARD, INC.EZS2024-11-12
30885632431122HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431132HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431149HalyardO&M HALYARD, INC.EZS2024-11-12
10810040134804Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
10810040134828Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134777Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134784Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134807Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134821Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134876Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134883Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134906Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08