FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00885825011703
·
Model: N/A
·
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00885825011703
- Version / Model
- N/A
- Catalog Number
- 408309
- Company Name
- STRYKER SUSTAINABILITY SOLUTIONS, INC.
- Labeler DUNS
- 020198912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ff6ed760-69b5-4c85-b301-6bae5fdaa4a4
Device Description
Small Curl Catheter Introducer Sheath 11.5 OD/8.5F ID, 8.5F dilator, 94cm dilator length, 91 lumen length, 180cm guidewire length
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61808 | Vascular guide-catheter, reprocessed | A sterile, flexible, single-lumen tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a previously used single-use device that has been processed for an additional single-use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885825011703 | GS1 |
Customer Contacts
- Phone
- +1(888)888-3433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123334 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 71.0 | Centimeter | |
| Device Size Text, specify | Diameter: 0.032 Inch |