FDA UDI
In Commercial Distribution
🇺🇸 United States
FABCO
DI: 30634303026033
·
Model: 35200511
·
FIRST AID BANDAGE CO INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- FABCO
- Primary DI
- 30634303026033
- Version / Model
- 35200511
- Catalog Number
- 35200511
- Company Name
- FIRST AID BANDAGE CO INC
- Labeler DUNS
- 001137280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2019-03-15
- Public Version
- 1
- Public Version Date
- 2019-03-25
- Public Version Status
- New
- Public Device Record Key
- 540909d3-514c-42c2-8e97-3afb24e19a01
Device Description
“K” Dissectors, Sewn
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13698 | Dissection sponge | A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30634303026033 | GS1 | ||||
| Unit of Use | 00634303026032 | GS1 |
Customer Contacts
- Phone
- (860) 443-8499
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15.9 | Millimeter | |
| Outer Diameter | 5 | Millimeter | |
| Length | .625 | Inch | |
| Outer Diameter | .25 | Inch |