FDA.reportPublic FDA data

MEDI-FRIG

Primary DI
00841494103866
Brand
MEDI-FRIG
Company
Cynosure, LLC
Model
H11B
Catalog number
H11B
Device description
MEDI-FRIG, ONE CANISTER (280G) W STRAW
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JEHPLETHYSMOGRAPH, VOLUME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEHPlethysmograph, VolumeAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954703000MEDI-FRIGEllman Intl., Inc.1996-02-08GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494103866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494103866008414941038668414941038660841494103866

GMDN Terms#

Term, Definition table
TermDefinition
Cryogenic spray, dentalA liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24
00841494106980PicoSure 532 Delivery System100-7012-5322017-07-24
00841494106997PicoSure 1064 Delivery System100-7012-1642017-07-24
00841494107246Refusrbished, Handpiece, 1064, PicoR100-7012-0792017-07-24
00841494107253Refusrbished, Handpiece, 532, PicoR100-7012-0762017-07-24
00841494104214PERF-GRIDEPG107EPG1072016-09-21
00841494104689SPLINT GRID NYLON MESH ROLLESG118ESG1182016-09-21
00841494104696SPLINT MESH STAINLESS STEEL MESH ROLLESG117ESG1172016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613365501193PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
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07613365501223PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
07613365501230PowerCube+ Series Ganshorn Medizin Electronic GmbHJEH2025-03-31
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07613365501254PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
07613365500301PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365500400PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365500431PowerCube+ Series Ganshorn Medizin Electronic GmbHJEH2024-12-20
07613365501018PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365501032PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365501070PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
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05099169916104VitaloQUBVITALOGRAPH (IRELAND) LIMITEDJEH2023-06-09
14250892903726VyaireJaeger Medical GmbHJEH2021-04-01
14250892903900VyaireJaeger Medical GmbHJEH2021-04-01
14250892903917VyaireJaeger Medical GmbHJEH2021-04-01
04250892905693VyaireJaeger Medical GmbHJEH2021-01-21
14250892905799VyaireJaeger Medical GmbHJEH2021-01-21
04250892904672VyaireJaeger Medical GmbHJEH2019-10-14
04250892904689VyaireJaeger Medical GmbHJEH2019-10-14
00817065022478HokansonD.E.HOKANSON, INC.JEH2018-03-01