FDA UDI
In Commercial Distribution
🇺🇸 United States
FABCO
DI: 30634303550125
·
Model: 35504410
·
FIRST AID BANDAGE CO INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- FABCO
- Primary DI
- 30634303550125
- Version / Model
- 35504410
- Catalog Number
- 35504410
- Company Name
- FIRST AID BANDAGE CO INC
- Labeler DUNS
- 001137280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-12-31
- Public Version
- 1
- Public Version Date
- 2019-01-31
- Public Version Status
- New
- Public Device Record Key
- cc9c22eb-a98c-4bfa-8d26-b5dfb7b131fb
Device Description
Neutec® Neurological Pattie • 1-1/2 X 1-1/2 Rayon, X-Ray Detectable
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13702 | Neurosurgical sponge | A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50634303550129 | GS1 | Dispenser Box | 20 | In Commercial Distribution | |
| Primary | 30634303550125 | GS1 | ||||
| Unit of Use | 00634303550124 | GS1 |
Customer Contacts
- Phone
- (860) 443-8499
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 38.1 | Millimeter | |
| Length | 38.1 | Millimeter | |
| Width | 1.5 | Inch | |
| Length | 1.5 | Inch |