FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 04546540898562
·
Model: 0300040000
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04546540898562
- Version / Model
- 0300040000
- Catalog Number
- 0300-040-000
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 2
- Public Version Date
- 2021-09-27
- Public Version Status
- Update
- Public Device Record Key
- 20bf08ba-2429-4b8b-87a9-3c10b84c263a
- Distribution End Date
- 2021-07-01
Device Description
Bucket Liners
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LGG | INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL | Orthopedic | 888.5980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12223 | Bucket liner | A device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 34546540898563 | GS1 | pack | 100 | Not in Commercial Distribution | 2021-07-01 |
| Primary | 04546540898562 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]