FDA.reportPublic FDA data

NA

Primary DI
10705034722597
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
03.804.413S
Catalog number
03804413S
Device description
INFLATION SYSTEM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
Not 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
NDNCEMENT, BONE, VERTEBROPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110604000VBB SYSTEMSynthes2011-12-13NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034722597PrimaryGS10
H98103804413S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503472259710705034722597

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
832637081
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034731650NA03.820.126038201262016-12-31
10705034731667NA03.820.127038201272016-12-31
10705034731674NA03.820.128038201282016-12-31
10705034731681NA03.820.129038201292016-12-31
10705034731759NA03.820.136038201362016-12-31
10705034731766NA03.820.137038201372016-12-31
10705034731896PRODISC L03.820.201038202012016-12-31
10705034731902PRODISC L03.820.202038202022016-12-31
10705034732008NA03.820.459038204592016-12-31
10705034732015NA03.820.462038204622016-12-31
10705034763729ProDisc-C09.820.025S09820025S2014-09-08
10705034763736ProDisc-C09.820.026S09820026S2014-09-08
10705034763750ProDisc-C09.820.035S09820035S2014-09-08
10705034763767ProDisc-C09.820.036S09820036S2014-09-08
10705034763781ProDisc-C09.820.045S09820045S2014-09-08
10705034763798ProDisc-C09.820.046S09820046S2014-09-08
10705034763804ProDisc-C09.820.047S09820047S2014-09-08
10705034763811ProDisc-C09.820.055S09820055S2014-09-08
10705034763828ProDisc-C09.820.056S09820056S2014-09-08
10705034763835ProDisc-C09.820.057S09820057S2014-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800038029323SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03