NA
- Primary DI
- 04058749119237
- Brand
- NA
- Company
- Fehling Instruments GmbH & Co. KG
- Model
- MNK-8U
- Catalog number
- MNK-8U
- Device description
- SUPERPLAST vascular probe straight, 2.25 x 140 mm, US-Version
- Published
- 2024-03-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
fehlingsurgical.comProduct Codes
| Code | Name |
|---|---|
| DWP | Dilator, Vessel, Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DWP | Dilator, Vessel, Surgical | Cardiovascular | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K220981 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04058749119237 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04058749119237 | 04058749119237 | 4058749119237 |
GMDN Terms
| Term | Definition |
|---|---|
| Vascular dilator, reusable | A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| 800 334-5464 | info@fehlingsurgical.com |
Regulatory Flags
- DUNS number
- 315028238
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04058749009538 | NA | BSI-3 | BSI-3 | 2026-03-05 |
| 04058749009811 | NA | BSK-8 | BSK-8 | 2026-03-05 |
| 04058749009873 | NA | BSL-4 | BSL-4 | 2026-03-05 |
| 04058749009903 | NA | BSL-7 | BSL-7 | 2026-03-05 |
| 04058749027327 | NA | KOL-5 | KOL-5 | 2026-03-05 |
| 04058749027457 | NA | KOM-5 | KOM-5 | 2026-03-05 |
| 04058749028102 | NA | KOV-9 | KOV-9 | 2026-03-05 |
| 04058749036152 | NA | MBM-2 | MBM-2 | 2026-03-05 |
| 04058749039832 | NA | MLC-2V | MLC-2V | 2026-03-05 |
| 04058749043082 | NA | MPA-3L | MPA-3L | 2026-03-05 |
| 04058749043099 | NA | MPA-3R | MPA-3R | 2026-03-05 |
| 04058749043143 | NA | MPA-7 | MPA-7 | 2026-03-05 |
| 04058749043150 | NA | MPA-8 | MPA-8 | 2026-03-05 |
| 04058749043167 | NA | MPA-9 | MPA-9 | 2026-03-05 |
| 04058749043266 | NA | MPC-0A | MPC-0A | 2026-03-05 |
| 04058749046304 | NA | MRY-8 | MRY-8 | 2026-03-05 |
| 04058749047752 | NA | MSY-6 | MSY-6 | 2026-03-05 |
| 04058749055276 | NA | NLA-6 | NLA-6 | 2026-03-05 |
| 04058749078770 | NA | NVO-2 | NVO-2 | 2026-03-05 |
| 04058749082357 | NA | NZO-8K | NZO-8k | 2026-03-05 |
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|---|---|---|---|---|
| 00846159035926 | SCANLAN® Forceps | SCANLAN INTERNATIONAL INC | DWP | 2025-11-13 |
| 00887482160893 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | DWP | 2024-08-14 |
| 00190776387617 | Millennium | Avalign Technologies, Inc. | DWP | 2024-05-10 |
| 00190776387624 | Millennium | Avalign Technologies, Inc. | DWP | 2024-05-10 |
| 00190776387631 | Millennium | Avalign Technologies, Inc. | DWP | 2024-05-10 |
| 00190776387648 | Millennium | Avalign Technologies, Inc. | DWP | 2024-05-10 |
| 04058749118773 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749118827 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749118834 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749118841 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749118858 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749119015 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749119022 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749119039 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749119046 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749119121 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749119138 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749119145 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-04-09 |
| 04058749118803 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-03-27 |
| 04058749119190 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-03-27 |
| 04058749119213 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-03-27 |
| 04058749119244 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2024-03-27 |
| 00810123206582 | Adler Instrument Company | Adler, Inc. | DWP | 2023-12-14 |
| 04058749118810 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2023-12-08 |
| 04058749119183 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2023-12-08 |
| 04058749119206 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2023-12-08 |
| 04058749118957 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2023-12-06 |
| 04058749119053 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2023-12-06 |
| 04058749119114 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2023-12-06 |
| 04058749119220 | NA | Fehling Instruments GmbH & Co. KG | DWP | 2023-12-06 |