FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vitagel
DI: 00808232001389
·
Model: 2113-0211
·
Stryker Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Vitagel
- Primary DI
- 00808232001389
- Version / Model
- 2113-0211
- Catalog Number
- 2113-0211
- Company Name
- Stryker Corporation
- Labeler DUNS
- 149183167
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 5
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 9e9d5b54-50ea-4b42-b24e-e5fcb38ad60c
- Distribution End Date
- 2018-06-30
Device Description
RT3 REACH9 Malleable Applicator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| LMF | Agent, absorbable hemostatic, collagen based | General, Plastic Surgery | 878.4490 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47186 | Haematological concentrate/haemostatic agent applicator | A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30808232001380 | GS1 | pack | 5 | Not in Commercial Distribution | 2018-06-30 |
| Primary | 00808232001389 | GS1 |
Customer Contacts
- Phone
- +1(610)640-1775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P050044 | 028 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius