FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vitagel
DI: 30808232000833
·
Model: 2090-0036
·
Stryker Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Vitagel
- Primary DI
- 30808232000833
- Version / Model
- 2090-0036
- Catalog Number
- 2090-0036
- Company Name
- Stryker Corporation
- Labeler DUNS
- 149183167
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2019-05-16
- Public Version Status
- Update
- Public Device Record Key
- 1b9afbfb-37ff-43bc-ac3a-2fcbebcd8557
- Distribution End Date
- 2018-06-30
Device Description
Spray Set
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
- 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 |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47185 | Haematological concentrate system delivery unit | A mains electricity (AC-powered) device that is a component of a haematological concentrate system and used to deliver a processed haematological concentrate through tubing to a hand-held applicator (typically a spraypen or endoscopic applicator). Upon activation (e.g., via a foot-switch operated by surgical staff) it typically generates a low pressure for the delivery of the concentrate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30808232000833 | GS1 | ||||
| Unit of Use | 00808232000832 | GS1 |
Customer Contacts
- Phone
- +1(610)640-1775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052173 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry and Ambient