FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00815634020313
·
Model: 0600127
·
Micromedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00815634020313
- Version / Model
- 0600127
- Company Name
- Micromedics, Inc.
- Labeler DUNS
- 066839630
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-25
- Public Version
- 4
- Public Version Date
- 2023-04-25
- Public Version Status
- Update
- Public Device Record Key
- 2f75452c-4ba2-4445-947a-9390354b6ee0
Device Description
2-Part Endoscopic Applicator with Malleable Tip
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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58451 | Fibrin sealant biochemical preparation/application kit, endoscopic | A collection of sterile devices designed to be used for the biochemical preparation and subsequent delivery of autologous fibrin sealant to a site of intervention during an endoscopic surgical procedure (e.g., to achieve haemostasis, seal air leaks, adhere tissues). It typically consists of a dedicated preparation unit (a cassette) with a collection of application devices including an endoscopic applicator, needle, and tubing. Patient blood is contained within the preparation unit which is placed in a production unit (processor) which controls the biochemical processes and centrifugation to produce the fibrin sealant. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815634020313 | GS1 | ||||
| Package | 10815634020310 | GS1 | SHELFL BOX | 6 | In Commercial Distribution | |
| Package | 20815634020317 | GS1 | SHIP BOX | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123847 | 000 |