FDA Registration
Active
🇩🇪 Germany
USTOMED INSTRUMENTE GMBH & CO. KG
Reg #: 3002808270
·
FEI: 3002808270
·
Expires 2026
Products
90
Proprietary Names
2
Establishment Types
3
Classifications
90
Registration Details
- Registration Name
- USTOMED INSTRUMENTE GMBH & CO. KG
- Registration Number
- 3002808270
- FEI Number
- 3002808270
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bischof Sproll Str. 2
- City
- Tuttlingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K123234
Owner / Operator
- Firm Name
- USTOMED INSTRUMENTE GMBH & CO. KG
- Operator Number
- 10048936
- Address
- Bischof Sproll Str. 2
- City
- Tuttlingen
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
- Correspondent
- Oliver Keuffel
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2018-04-16 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2018-04-13 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2018-04-13 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2018-04-16 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2018-04-16 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2015-04-20 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | Class 1 | Ear, Nose, Throat | No | 2018-04-13 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2018-04-16 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2018-04-16 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2016-08-30 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2018-04-13 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2018-04-13 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2018-04-16 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2018-04-16 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2018-04-16 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2018-04-13 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2016-11-08 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2022-03-09 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2015-04-20 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2018-04-16 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2015-04-20 |
| Bone Particle Collector | MXP | Class 1 | Ear, Nose, Throat | No | 2018-04-13 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2018-04-13 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2018-04-13 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2022-05-04 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2022-03-09 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2022-03-09 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2018-04-13 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2022-03-09 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2018-04-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2018-04-13 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2018-04-16 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2022-03-09 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2018-04-13 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2018-04-13 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2018-04-13 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2018-04-13 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2022-03-09 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2018-04-16 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2018-04-13 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2015-04-20 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2018-04-16 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2018-04-16 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2018-04-13 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2018-04-13 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2018-04-13 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 2015-04-20 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2018-04-16 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2018-04-16 |
| Dilator, Esophageal, Ent | KCF | Class 1 | Ear, Nose, Throat | No | 2015-04-20 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2022-03-09 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2015-04-20 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2022-03-09 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2018-04-16 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2018-04-13 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2018-04-13 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2018-04-16 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2018-04-16 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Instrument, Contouring, Matrix, Operative | EKF | Class 1 | Dental | No | 2022-03-09 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2022-03-09 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2016-08-31 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2018-04-16 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2018-04-16 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2018-04-13 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2016-08-30 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2018-04-13 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2018-04-13 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2018-04-16 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2018-04-13 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2015-04-20 |
Proprietary Names
Aspirateur de Yankauer
Splinter forceps
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)