FDA UDI
In Commercial Distribution
🇺🇸 United States
Imbibe
DI: 07613327123579
·
Model: 2090-9030
·
Stryker Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Imbibe
- Primary DI
- 07613327123579
- Version / Model
- 2090-9030
- Catalog Number
- 2090-9030
- Company Name
- Stryker Corporation
- Labeler DUNS
- 149183167
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-02-25
- Public Version Status
- Update
- Public Device Record Key
- 3c7596f5-c5bd-45cc-b858-ae94135de11b
Device Description
Fenestrated Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
| KNW | INSTRUMENT, BIOPSY | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35886 | Body aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327123579 | GS1 |
Customer Contacts
- Phone
- +1(610)640-1775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153306 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15.0 | Centimeter | |
| Needle Gauge | 8.0 | Gauge |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius