Who else makes this device?

Name: OptaBlate
Brand: OptaBlate

OptaBlate · Probe, Radiofrequency Lesion → Neurology

1manufacturer

2catalogue numbers in this listing

2recalls on this code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GXI
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for OptaBlate
Listed by	Stryker GmbH, Switzerland
FDA product code	GXI
Device type	Probe, Radiofrequency Lesion
Device class	Class 2
Regulation	21 CFR 882.4725
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Record published	2025-05-27

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Handling environment humidity 10 to 75 % RH; Handling environment temperature -20 to 40 °C; Storage environment humidity 10 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 40 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal

Catalogue Numbers

Catalogue numbers for OptaBlate
Catalogue number	Size	Status
9900110100		In distribution
9900110200		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
OWL	Diros Technology, Inc.	345
Probe, Radiofrequency Lesion	Boston Scientific Neuromodulation Corporation	175
Halyard	Avanos Medical, Inc.	156
Lccs	Lccs Products Limited	101
Epimed	Epimed International, Inc.	100
Avanos	Avanos Medical, Inc.	89
NeuroTherm™	Neurotherm, Inc.	87
Probe, Radiofrequency Lesion	St. Jude Medical	66
cannulaRFK	Cosman Medical, Inc.	56
Rftl	Pajunk Gmbh Medizintechnologie	54
Radiofrequency (RF) Needle	Spectra Medical Devices, LLC	49
cannulaCC	Cosman Medical, Inc.	47

Showing 12 of 85. All products under Probe, Radiofrequency Lesion

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-07-17	Class II	Labeling mix-ups	Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannu	226	2013-05-02
2012-07-17	Class II	Labeling mix-ups	Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannu	210	2013-05-02

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.

OptaBlate