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
Rx
false
OTC
true
Sterile
false
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
Noninvasive faecal incontinence collectorA noninvasive device intended to be used for the collection of stool (faeces) from a patient who is unable to control stool discharge. It may be in the form of: 1) a collection bag/pouch which attaches to incontinence underwear [pants], the skin around the anus (e.g., via an adhesive hydrocolloid wafer), or to an invasive rectal catheter [not included]; or 2) an external 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618029980052Sage Fecal Management System700-118700-1182021-10-15
00618029830128Q-Care Rx6904-PS6904-PS2023-09-07
00618029810328Toothette Oral Care400040002016-09-24
00618029830081Q-Care690469042016-09-24
00618029830166Q-Care691269122016-09-24
00618029830173Q-Care691469142016-09-24
00618029830753Q-Care696469642016-09-24
00618029830760Q-Care696269622016-09-24
00618029830975Q-Care697469742019-07-10
00618029831125Q-Care699269922018-12-10
00618029831149Q-Care Rx698269822018-12-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00610075031849HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075031863HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075033263Karaya 5HOLLISTER INCORPORATEDEXB2022-12-01
00610075037742PouchkinsHOLLISTER INCORPORATEDEXB2022-12-01
00610075051762New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051779New ImageHOLLISTER INCORPORATEDEXB2022-12-01
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