FDA.reportPublic FDA data

Bailey Retractable Monofilament 10g

Primary DI
05060418832285
Brand
Bailey Retractable Monofilament 10g
Company
BAILEY INSTRUMENTS LTD
Model
CH537
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXBEsthesiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXBEsthesiometerNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060418832285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060418832285050604188322855060418832285

GMDN Terms#

Term, Definition table
TermDefinition
Point aesthesiometerA manual stimulator designed to determine tactile sensibility by patient response to the manual application of a thin filament(s) to the skin. It typically consists of a filament(s) with a pre-set flexibility and is intended to apply a known pressure upon application; the filament is attached to an appropriate handle/base that may also be intended to be loaded into a dedicated pen/holder. The device is typically used during diagnosis or treatment of nerve injuries and neuropathies associated with e.g., diabetes mellitus or leprosy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
769260357
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05060418833343Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833695Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418833725Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418833732Susol® Diamond Bur 15CS-DB72024-02-27
05060418833749Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418833992Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418834012Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418834029Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418833671Susol® Emery Board 18cmCH1452024-02-27
05060418832377Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418832407Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418832414Susol® Diamond Bur 15CS-DB72024-02-27
05060418832421Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418832674Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418832698Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418832704Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418836177Susol® Micro Curette Double Ended with holeSS62-43002024-02-27
05060418834883 Susol® Nail Care SetBSDP-022024-02-20
05060418833640 Susol® Nail Care SetBSDP-022024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908022363016NEURO TOUCHYOSTRA LABS PRIVATE LIMITEDGXB2024-01-10
00609271039803DARCO® Monofilament TesterDARCO INTERNATIONAL, INC.GXB2023-02-08
00609271000094DARCO® Foot FilamentDARCO INTERNATIONAL, INC.GXB2023-02-08
10609271039800DARCO® Monofilament TesterDARCO INTERNATIONAL, INC.GXB2023-02-08
04262355230501The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230532The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230549The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230556The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230563The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
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04262355230693The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355232109OptiHair2MRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
05060631140006Medipin MEDIPIN LIMITEDGXB2021-03-25
05060631140013MedipinMEDIPIN LIMITEDGXB2021-03-25
00384700100018NeuropenOWEN MUMFORD LIMITEDGXB2019-10-03
00384700104016Neuropen Monofilaments 10gOWEN MUMFORD LIMITEDGXB2019-10-03
00384705405019NeurotipsOWEN MUMFORD LIMITEDGXB2019-10-03
00384700100032NeuropenOWEN MUMFORD LIMITEDGXB2019-10-03
00384700104030Neuropen Monofilaments 10gOWEN MUMFORD LIMITEDGXB2019-10-03
00384705405033NeurotipsOWEN MUMFORD LIMITEDGXB2019-10-03