FDA.reportPublic FDA data

NA

Primary DI
10886982194404
Brand
NA
Company
Synthes GmbH
Model
352.229S
Catalog number
352229S
Device description
GRAFT FILTER FOR RIA-STERILE
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXARTHROSCOPE
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HTOReamerOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042899000
K111437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042899000SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONSSynthes (Usa)2005-03-16HTO
K111437000SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)Synthes (USA) Products, LLC2011-08-10HTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982194404PrimaryGS10
H679352229S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698219440410886982194404

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft harvesting filterA sterile receptacle designed to collect morselized (cut/shredded into small pieces) bone and bone marrow typically obtained during an intramedullary procedure involving reaming, irrigation, and aspiration (suction). The filter is situated, with connection tubing, between the bone harvesting device (e.g., the orthopaedic reamer handpiece) and a suction system which creates vacuum to draw the graft into the filter where it is captured. The retrieved tissue is used for surgical procedures requiring bone graft (e.g., to facilitate bone fusion and/or fill bone defects). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011690Arthroscope Ø 2.7 mm, 30°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011706Arthroscope Ø 2.7 mm, 70°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
00850033250428Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HRX2022-09-07
00850033250435Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HRX2022-09-07
04035873066705N/AHenke-Sass, Wolf GmbHHRX2021-02-16
04035873066651N/AHenke-Sass, Wolf GmbHHRX2021-02-12
04035873066668N/AHenke-Sass, Wolf GmbHHRX2021-02-12
04035873066675N/AHenke-Sass, Wolf GmbHHRX2021-02-12
04035873066682N/AHenke-Sass, Wolf GmbHHRX2021-02-12
04035873066699N/AHenke-Sass, Wolf GmbHHRX2021-02-12
04035873066583N/AHenke-Sass, Wolf GmbHHRX2021-02-10
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