FDA Registration
Active
🇺🇸 United States
WOLF X-RAY CORP
Reg #: 2431224
·
FEI: 2431224
·
Expires 2026
Products
29
Proprietary Names
46
Establishment Types
4
Classifications
29
Registration Details
- Registration Name
- WOLF X-RAY CORP
- Registration Number
- 2431224
- FEI Number
- 2431224
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 133 Wolf Road
- City
- Battleboro
- State
- NC
- ZIP
- 27809
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090131
Owner / Operator
- Firm Name
- Wolf X-Ray Corp
- Operator Number
- 2431224
- Address
- 133 Wolf Road
- City
- Battleboro
- State
- NC
- Postal Code
- 27809
- Country
- US
- Correspondent
- Carolyn Price
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2016-04-11 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-03-28 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-28 |
| Cassette, Radiographic Film | IXA | Class 2 | Radiology | No | 2019-11-05 |
| Grid, Radiographic | IXJ | Class 1 | Radiology | No | 2019-11-05 |
| Screen, Intensifying, Radiographic | EAM | Class 1 | Radiology | No | 2019-05-13 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2017-02-24 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2023-08-08 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2013-12-11 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-27 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2016-04-11 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2023-03-09 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2016-04-11 |
| Apron, Leaded | EAJ | Class 1 | Radiology | No | 2016-04-11 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2016-05-03 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2019-11-05 |
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2019-11-05 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2026-03-09 |
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 1977-11-07 |
| Shield, Gonadal | IWT | Class 1 | Radiology | No | 2023-05-16 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2007-03-05 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2019-01-25 |
| Curtain, Protective, Radiographic | IWQ | Class 1 | Radiology | No | 2023-07-17 |
| Barrier, Control Panel, X-Ray, Movable | IWX | Class 1 | Radiology | No | 2016-04-11 |
| Aligner, Beam, X-Ray | EHA | Class 1 | Dental | No | 2007-03-05 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2023-03-15 |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | Class 1 | Radiology | No | 2019-06-13 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2016-04-11 |
| Illuminator, Radiographic-Film | IXC | Class 1 | Radiology | No | 2016-04-11 |
Proprietary Names
PROTECTIVE COLLAR
N95 Mask
CASSETTE RADIOGRAPHIC
RADIOGRAPHIC GRID
Wolf X-Ray intensifying screens
X-Ray Film Marking
Table Pads
EXPOSURE DOUBLE ARTICULATING FILM
EXPOSURE ARTICULATING FILM
SAFE-T-FIRST FACE SHIELD
APRON PROTECTIVE
Tranzform Apron Hanger
Perfect Fit
EYEGLASS SHIELD PROTECTIVE
APRON (LEAD)
SteriTatt Ink, SteriTatt Cartridge,SteriTattDropper
Steritatt ink dispenser
COMPRESSION PADDLE
MAGNIFYING GLASS
Perfect Shape
Butterfly Safety Shield
Developer & Fixer
Dental X-ray Film
Gonad Shield
All-Bite, Digi Loops
SMART Positioning System
Safe 'n' Sure 3V PSP Envelopes Sizes 0, 1, 2
Sensibles, Bite Blocks, RAPiD
Safe 'n' Sure OPT PSP Envelopes Sizes 0, 1, 2, 3
Endodontic Positioner
Uni-Verse-All Positioner
Sticky Bites, SUPAs, Stickems, Loop EZ, Cushies, Deluxe Cushies
Safe 'n' Sure Deluxe and Econo PSP Envelopes Sizes 0, 1, 2, 3
Snuggies, Comfees
Bite Block Baggies
DispozaSleeves
Sand bag
Pro-Lock Rad Foam
Wolfoam Positioning Blocks
Shield Under Table
BARRIER
Bullseye Alignment Device
Barium Cup
Wolf X-Ray Cassette Holder
PROTECTIVE GLOVES
ILLUMINATOR
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198