FDA.reportPublic FDA data

Stryker Fecal Management System

Primary DI
00618029980274
Brand
Stryker Fecal Management System
Company
SAGE PRODUCTS, LLC
Model
700-128
Catalog number
700-128
Device description
Stryker Fecal Management System
Published
2023-03-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXBCOLLECTOR, OSTOMY
GDSBAG, STOMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1
GDSBag, StomalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029980279PackageGS110Not in Commercial Distribution
00618029980274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802998027950618029980279
00618029980274006180299802746180299802740618029980274

GMDN Terms#

Term, Definition table
TermDefinition
Faecal incontinence collector, skin-fixationA device intended to be used for the collection of liquid or semi-liquid stool (faeces) from a patient who is unable to control stool discharge. It may be in the form of a collection bag/pouch which attaches to the skin around the anus (e.g., via an adhesive hydrocolloid wafer), or an external catheter-like tube intended to noninvasively attach to the perianal skin (e.g., via a flange) to drain faecal matter to an attached pouch; it typically has a flushing and/or drainage port. It is made of soft plastic materials and may have deodorizing capability. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-2220customer-service-spcl@sageproducts.com

Regulatory Flags#

DUNS number
054326178
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618029831118Q-Care906290622018-08-10
00618029720801Sage Air Tap LC728772872019-10-01
07613327680720Q-Care682268222025-12-03
07613327680737Q-Care694269422025-12-03
07613327680744Q-Care698469842025-12-03
07613327680751Q-Care682468242025-12-03
57613327680725Q-Care682268222025-12-03
57613327680732Q-Care694269422025-12-03
57613327680749Q-Care698469842025-12-03
57613327680756Q-Care682468242025-12-03
07613327632842Sage Multi-Position MATS 2.0323432342025-11-19
07613327632859Sage325032502025-11-19
07613327632866Sage325132512025-11-19
07613327672718Sage Multi-Position MATS 2.0323132312025-11-19
00618029720856Sage AirTAP LC728972892020-04-20
00618029760869Sage Multi-Position MATS323232322021-10-15
07613327632835Sage Multi-Position MATS323332332024-08-12
07613327632873Sage TAP LC728172812024-03-26
07613327632880Sage TAP LC728272822024-03-26
57613327632830Sage Multi-Position MATS323332332024-08-12

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Primary DI, Brand, Company table
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10885632431197HalyardO&M HALYARD, INC.GDS2024-11-12
09421905447195The Insides NeoTHE INSIDES COMPANY LIMITEDEXB2023-05-26
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