| Primary Device ID | 56932503524105 |
| NIH Device Record Key | c38eab98-69b8-4f32-aea5-775111da12e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ABC Dilatation Balloon Catheter |
| Version Model Number | FWB-12/80-6/18-S |
| Company DUNS | 530269083 |
| Company Name | Micro-Tech (Nanjing) Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com | |
| Phone | 877-552-4027 |
| info@micro-tech-usa.com |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Balloon Diameter | 12 Millimeter |
| Balloon Length | 8 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 46932503524108 [Primary] |
| GS1 | 56932503524105 [Package] Contains: 46932503524108 Package: BOX [2 Units] In Commercial Distribution |
| GS1 | 66932503524102 [Package] Package: CASE [25 Units] In Commercial Distribution |
| KNQ | Dilator, Esophageal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-15 |
| Device Publish Date | 2025-12-06 |
| 56932503524150 | the balloon diameter is 20mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the wo |
| 56932503524143 | the balloon diameter is 18mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the wo |
| 56932503524129 | the balloon diameter is 15mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the wo |
| 56932503524105 | the balloon diameter is 12mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the wo |
| 56932503524099 | the balloon diameter is 10mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the wo |
| 56932503524082 | the balloon diameter is 8mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the wor |
| 56932503524075 | the balloon diameter is 6mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the wor |