FDA.reportPublic FDA data

POCKET

Primary DI
03700542625040
Brand
POCKET
Company
QUANTEL MEDICAL
Model
POCKET II
Device description
Ultrasonic Pachymeter for Glaucoma Screening and Refractive Surgery.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700542625040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700542625040037005426250403700542625040

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound pachymeterA mains electricity (AC-powered), ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. A small ultrasound probe(s) that is connected to this device is placed directly onto the cornea to make the measurements which are recorded and displayed by the pachymeter. The data is used to evaluate refractive eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], evaluate ocular measurements for calculating intraocular lens power, monitor epithelium regrowth, and for other ophthalmic measurement evaluations.

Contacts#

Phone, Email table
PhoneEmail
+33(0)473745745contact@quantel-medical.fr

Regulatory Flags#

DUNS number
738574953
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700542625958CAPSULOCAPSULO2025-03-25
03700542626009POCKET IIIPOCKET III2025-03-25
03700542625316SUPRA 577YSUPRA 577Y2016-09-23
03700542625941AXIALISAXIALIS2022-01-05
03700542625569VITRA 2 VITRA 2 2021-12-29
03700542625613VITRA 810VITRA 8102021-12-29
03700542625927EASYRETEASYRET2021-10-19
03700542625132VITRAVITRA2016-09-23
03700542625286SUPRASUPRA2016-09-23
03700542625415VITRA MULTISPOTVMS2016-09-23
03700542625484EASYRETEASYRET2017-09-11
03700542625224532nm Heine Omega IO with integrated adaptorIOH8105322016-09-23
03700542625231532nm adaptor for Keeler Vantage Plus IO (100µ)810532IOVPST2016-09-23
03700542625248Keeler Vantage Plus IOLAFVP22016-12-07
03700542625392577nm Heine Omega 500 IO with integrated adaptorIOH5772016-09-23
03700542625408577nm adaptor for Keeler Vantage Plus IO (100µ)577IOV1002016-09-23
03700542625521ABSOLUABSOLU2019-07-09
03700542625002AVISO (S)AVISO (S)2016-09-23
03700542625057B Probe 10MHz AVISOB1 AVISO2016-09-23
03700542625064B Probe 20MHz AVISOB-HF AVISO2016-09-23

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Primary DI, Brand, Company table
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00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126304Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00840432200216BladderScan®VERATHON INCIYO2026-07-22
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00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
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00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
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