FDA.reportPublic FDA data

Hi-Fi

Primary DI
10653405005476
Brand
Hi-Fi
Company
Conmed Corporation
Model
HT7110
Catalog number
HT7110
Device description
2MM Hi-Fi® Tape Blue
Published
2021-10-13
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
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100006000HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEEDRiverpoint Medical2010-05-10GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405005473PackageGS11Not in Commercial Distribution
10653405005476PrimaryGS10
00653405005479Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340500547320653405005473
1065340500547610653405005476
00653405005479006534050054796534050054790653405005479

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405546501Y-KnotlessTM FlexYKF-GYKF-G2026-02-06
20653405990724Y-KnotlessTM FlexYKF-WYKF-W2026-02-06
10845854027851GENESYS PRESSFT, HI-FINB211NB2112015-10-24
10845854027875GENESYS PRESSFT, HI-FINB212NB2122015-10-24
10845854027882GENESYS PRESSFT, HI-FINB261NB2612015-10-24
10845854027905GENESYS PRESSFT, HI-FINB262NB2622015-10-24
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653900497PremicronB BRAUN SURGICAL SAGAT2015-11-11
04038653914050PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653921980PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991822PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003853PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003914PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003921PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439020690PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991785PremicronB BRAUN SURGICAL SAGAT2015-11-05
10884521072657V-LocCovidien LPGAT2015-09-02
04038653983919PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653983544PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653750337PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653750450PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653871230PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900480PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900695PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900701PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900725PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653911035PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653922246PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439000944PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439001002PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439059072PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900503PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900510PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900732PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653988402PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653951048PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900541PremicronB BRAUN SURGICAL SAGAT2015-08-26