FDA UDI
In Commercial Distribution
🇺🇸 United States
FABCO
DI: 30634303800640
·
Model: Q600320
·
FIRST AID BANDAGE CO INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FABCO
- Primary DI
- 30634303800640
- Version / Model
- Q600320
- Catalog Number
- Q600320
- Company Name
- FIRST AID BANDAGE CO INC
- Labeler DUNS
- 001137280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-05
- Public Version
- 3
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 4c002037-9079-47f0-9572-fa87bed7e2ae
Device Description
Large Epistaxis Packing, No string
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| EMX | Balloon, Epistaxis | Ear, Nose, Throat | 874.4100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31919 | Intranasal splint, non-biodegradable | A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50634303800644 | GS1 | Dispenser Box | 20 | In Commercial Distribution | |
| Primary | 30634303800640 | GS1 |
Customer Contacts
- Phone
- (860) 443-8499
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1.5 | Centimeter | |
| Width | 2.5 | Centimeter | |
| Length | 10 | Centimeter |