FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 07613327483994
·
Model: 33136T
·
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 07613327483994
- Version / Model
- 33136T
- Catalog Number
- 33136T
- Company Name
- STRYKER SUSTAINABILITY SOLUTIONS, INC.
- Labeler DUNS
- 020198912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 2
- Public Version Date
- 2022-04-28
- Public Version Status
- Update
- Public Device Record Key
- cbe49e55-ff06-4b6e-9c03-beb23e4281e1
Device Description
Disposable 5 Lead Cable and Lead Wire System
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
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| IKD | CABLE, ELECTRODE | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61812 | Electrocardiographic lead set, reprocessed | A collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327483995 | GS1 | pack | 10 | In Commercial Distribution | |
| Primary | 07613327483994 | GS1 | ||||
| Package | 57613327483999 | GS1 | case | 10 | In Commercial Distribution | |
| Previous | 10817357020509 | GS1 |
Customer Contacts
- Phone
- +1(888)888-3433
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.0 | Feet |