GN Otometrics A/S
117 catalogue numbers from DISC ELECTR,GLD, 9MM,48 IN,RED, listed by Natus Medical Denmark ApS, Denmark, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
117catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Dong Guan Danchen Electrical Products Ltd. | Dong Guan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Natus Medical Denmark ApS, Denmark |
|---|---|
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K083399 |
| Record published | 2016-09-20 |
| Record revised | 2025-10-30 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Distribution end date | 2020-12-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DISC ELECTR,GLD, 9MM,48 IN,RED | In distribution | |
| ABR Kit (normal cable) | In distribution | |
| ELECTR LD, SNAP, 24 IN, GREEN | In distribution | |
| Acoustic filters (10 pcs) | In distribution | |
| ELECTR LD,EP,SNAP,24 IN, PKG/5 | In distribution | |
| Ear couplers for binaural ABR, 25 sets of 2 | In distribution | |
| ENG CBL,7-LD,USED W/O PREAMP | In distribution | |
| “AccuScreen Starter Kit | In distribution | |
| Earhugs, disposables | In distribution | |
| ELECTR LD, SNAP, 40 IN, BLACK | In distribution | |
| 1068, CHARTR 200 LIGHT BAR KIT | In distribution | |
| MADSEN AccuScreen | In distribution | |
| DISC ELECTR,GLD, 9MM,48 IN,BRN | In distribution | |
| MADSEN Alpha OAE | In distribution | |
| ELECTR LD, SNAP, 40 IN, BROWN | In distribution | |
| “Eartip 4.0 mm pastel green | In distribution | |
| “Eartip 4,5 mm pastel pink | In distribution | |
| Insert Phone, 300 OHM, 1,2M, MATCH | In distribution | |
| ELECTR LD, SNAP, 40 IN, ORANGE | In distribution | |
| “Eartip 4,0 mm dark blue (250 pcs) | In distribution | |
| 1047, FACE CUSHION | In distribution | |
| TDH HEADPHONES, EP 200 | In distribution | |
| Small Tip Kit | In distribution | |
| Electrodes, snap, disposables (1 x 3 packs) | In distribution | |
| MADSEN AccuScreen | In distribution | |
| ELECTRODE JUMPER, 4 INCHES | In distribution | |
| Probe tip for TEOAE (pack of 5 pcs) | In distribution | |
| Eartip 6.5mm green mushroom type (50 pcs) | In distribution | |
| DISC ELECTR,GLD, 9MM,48 IN,BLK | In distribution | |
| ELECTR LD, SNAP, 40 IN, GREEN | In distribution | |
| ELECTR LD,ENG,SNAP,24 IN PKG/5 | In distribution | |
| Eartip yellow tree type 4-7mm (50 pcs) | In distribution | |
| Electrodes, snap, disposables (450 x 3 packs) | In distribution | |
| Electrodes, snap, disposables (25 x 3 packs) | In distribution | |
| MADSEN AccuScreen | In distribution | |
| “Eartip 6-10 mm yellow foam | In distribution | |
| ELECTR LEAD, SNAP, 40 IN. BLUE | In distribution | |
| ELECTR LD, SNAP, 24 IN, YELLOW | In distribution | |
| ELECTR LEAD, SNAP, 40 IN, RED | In distribution | |
| DISC ELECTR,GLD, 9MM,48 IN,BLU | In distribution | |
| Printer kit | In distribution | |
| DISC ELECTR,GLD, 9MM,48 IN,YEL | In distribution | |
| ELECTR LD, SNAP, 24 IN, WHITE | In distribution | |
| 1073, OTOINSERT CABLE KIT | In distribution | |
| Eartip 5mm green (50 pcs) | In distribution | |
| “Eartip 4.0 mm pastel green | In distribution | |
| “Eartip 5.0 mm pastel blue | In distribution | |
| “Eartip 3.7 mm pastel yellow | In distribution | |
| DISC ELECTR,GLD, 9MM,48 IN,ORN | In distribution | |
| ELECTR LD, SNAP, 24 IN, BROWN | In distribution | |
| “Eartip 4.5 mm red brown (50 pcs) | In distribution | |
| BONE CONDUCTION TRANS, EP 200 | In distribution | |
| CHARTR EP 200 VEMP MONIT. KIT | In distribution | |
| ICS Chartr EP 200 Insert, Bone 2 Ch, US only | In distribution | |
| DISC ELTRD,GLD,EP,9MM,48,PKG/5 | In distribution | |
| DSC ELTRD,GLD,EP,9MM,48IN,PK/8 | In distribution | |
| ELECTR LD,ENG,SNAP,24 IN PKG/7 | In distribution | |
| MADSEN AccuScreen, DP | In distribution | |
| “Eartip 3.7 mm pastel yellow | In distribution | |
| ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only | In distribution | |
| “Eartip kit (eartips, filters, | In distribution | |
| CTRL, REMOTE, FOR EP 200 | In distribution | |
| Disposable Diff VEMP Electrode | In distribution | |
| Eartip 5.5mm transparent blue (package of 50 pcs) | In distribution | |
| DISC ELECTR,GLD, 9MM,48 IN,GRN | In distribution | |
| MADSEN AccuScreen, TE | In distribution | |
| ELECTR LD,EP,SNAP,40 IN, PKG/5 | In distribution | |
| MADSEN AccuScreen, TE/DP | In distribution | |
| “Eartip 4-7 mm tree transparent | In distribution | |
| MADSEN Alpha OAE | In distribution | |
| ELECTR LD, SNAP, 24 IN, BLACK | In distribution | |
| “Eartip 4-7 mm tree, transparent | In distribution | |
| Eartip, Infant Silicone, 3mm, pkg/50 | In distribution | |
| ELECTR LD,ENG,SNAP,40 IN PKG/5 | In distribution | |
| DISC ELECTR,GLD, 9MM,48 IN,WHT | In distribution | |
| ELECTR LD, SNAP, 40 IN, YELLOW | In distribution | |
| MADSEN AccuScreen | In distribution | |
| ELECTR LD, SNAP, 24 IN, ORANGE | In distribution | |
| MADSEN AccuScreen | In distribution | |
| ELECTR LD,ENG,SNAP,40 IN PKG/7 | In distribution | |
| “Eartip yellow 4-7 mm tree (250 pcs) | In distribution | |
| ELECTR LD, SNAP, 40 IN, WHITE | In distribution | |
| ICS Chartr EP 200 Insert 2 Ch, US Only | In distribution | |
| “Eartip 4.5 mm pastel pink | In distribution | |
| “Eartip 5.0 mm pastel blue | In distribution | |
| ELECTR LEAD, SNAP, 24 IN, BLUE | In distribution | |
| ELECTR LEAD, SNAP, 24 IN. RED | In distribution | |
| Alpha Starter Kit | In distribution | |
| Eartip 8-11 mm Transparent Tree (bag of 50 pcs) | Withdrawn | |
| Eartip 9-13 mm Foam, Yellow (Bag of 250 pcs) | Withdrawn | |
| ABR tester | Withdrawn | |
| Eartip 9-13 mm Foam, Yellow (Bag of 50 pcs) | Withdrawn | |
| Probe Tip (10 pcs.) | Withdrawn | |
| Interface cable for label printer | Withdrawn | |
| Eartip 8-11 mm Transparent Tree (bag of 250 pcs) | Withdrawn | |
| LD, GOLD FOIL TIP-TRODE, PKG/2 | Withdrawn | |
| Alpha Docking Station Kit | Withdrawn | |
| Eartip 12-16 mm Blue Tree (Bag of 50 pcs) | Withdrawn | |
| Eartip 6-9 mm Blue Tree (Bag of 50 pcs.) | Withdrawn | |
| TIP-TRODE,ADLT GLD FOIL,PKG/20 | Withdrawn | |
| 1077, DOCKING UNIT KIT | Withdrawn | |
| Label printer kit | Withdrawn | |
| ECC for EarHugs | Withdrawn | |
| Probe for TEOAE/DPOAE | Withdrawn | |
| Eartip 12-16 mm Blue Tree (Bag of 250 pcs) | Withdrawn | |
| Ear Coupler Cable for Binaural ABR | Withdrawn | |
| Eartip 5 mm Blue (Bag of 250) | Withdrawn | |
| Eartip 5 mm Blue (Bag of 50) | Withdrawn | |
| External Battery Charger | Withdrawn | |
| Eartip 6-9 mm Blue Tree (Bag of 250 pcs.) | Withdrawn | |
| TIP-TRODE,PEDI GLD FOIL,PKG/20 | Withdrawn | |
| ABR Electrode Cable | Withdrawn | |
| Alpha DPOAE Probe (Grey) | Withdrawn | |
| Probe for TEOAE | Withdrawn | |
| AS, TEST CAVITY, 1.75 CCM | Withdrawn | |
| Probe Tip (10 pcs) | Withdrawn | |
| 1013, ABR EAR COUPLER 25 PAIRS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Natus Medical | Natus Medical Incorporated | 25 |
| QScreen Set | Path | 24 |
| AccuScreen | Natus Medical Denmark ApS | 20 |
| Natus | Natus Medical Incorporated | 18 |
| Sentiero Advanced | Path | 14 |
| Algo Pro | Natus Medical Denmark ApS | 9 |
| Algo Pro | Xltek | 9 |
| Stimulator, Auditory, Evoked Response | Medtronic Xomed, Inc. | 7 |
| Algo 3i | Natus Medical Denmark ApS | 5 |
| Teoae probe tips | Otodynamics, Ltd. | 5 |
| Algo 5 | Natus Medical Denmark ApS | 5 |
| ICS | Natus Medical Denmark ApS | 5 |
Showing 12 of 305. All products under Stimulator, Auditory, Evoked Response
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Natus Medical Denmark ApS | 510(k) number | 2019-05-28 | Class II | Device Design | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. | 3071 individual units | 2021-04-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.