FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Stryker Fecal Management System
DI: 00618029980274
·
Model: 700-128
·
SAGE PRODUCTS, LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Stryker Fecal Management System
- Primary DI
- 00618029980274
- Version / Model
- 700-128
- Catalog Number
- 700-128
- Company Name
- SAGE PRODUCTS, LLC
- Labeler DUNS
- 054326178
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-07
- Public Version
- 3
- Public Version Date
- 2026-02-26
- Public Version Status
- Update
- Public Device Record Key
- d6121f4f-ae93-425f-8f6f-b8bcfbb88d70
- Distribution End Date
- 2026-02-25
Device Description
Stryker Fecal Management System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDS | BAG, STOMAL | Gastroenterology, Urology | 876.5900 | 1 |
| EXB | COLLECTOR, OSTOMY | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62038 | Faecal incontinence collector, skin-fixation | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50618029980279 | GS1 | case | 10 | Not in Commercial Distribution | 2026-02-25 |
| Primary | 00618029980274 | GS1 |
Customer Contacts
- Phone
- +1(800)323-2220
- [email protected]