FDA.reportPublic FDA data

FINGER TRAPS, 5 MEDIUM, LITEGRIP

Primary DI
00842430115196
Brand
FINGER TRAPS, 5 MEDIUM, LITEGRIP
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
3460M-5
Catalog number
3460M-5
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQZComponent, Traction, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430112508PrimaryGS10
00842430115196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430112508008424301125088424301125080842430112508
00842430115196008424301151968424301151960842430115196

GMDN Terms#

Term, Definition table
TermDefinition
Upper-limb traction wrap/trap, reusableA preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of metal or synthetic polymer materials (e.g., nylon) with self-retaining fasteners (e.g., Velcro), and may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame; some types may be inflatable to provide grip by means of air pressure. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430112553LATERAL SUPPORT PAD ASSEMBLY5338-1005338-1002021-02-01
00842430101663TABLE, ProFx, REFURBISHED6850R6850R2020-09-09
00842430101977TABLE, INSITE, REFURBISHED6844R6844R2020-09-09
00842430115097SLING, REHAB SHOULDER, ABDUCTION8678672020-09-03
00842430112119IMMOBILIZER, SHOULDER, UNIVESAL,W/ STRAP146S146S2020-07-27
00842430100031Allegro Table Refurbished 120V, 60HZ6800R6800R2016-09-15
00842430104022ALUMINUM SIDE RAIL SOCKET539453942018-04-18
00842430104404PIVOTING ARM BOARD W/TEMPUR 2IN535653562018-04-18
00842430104497CMBU RADIOLUCENT DORO ADAPTER5979-3005979-3002018-05-10
00842430104503CMBU RADIOLUCENT MAYFIELD ADAPTER5979-2005979-2002018-05-10
00842430104541COUPLER II RADIOLUCENT DORO ADAPTER5873-3005873-3002018-04-26
00842430104947Levó Protective Arm Sleeve789278922019-03-08
00842430105098PIVOTING ARM BOARD W/TEMPUR 3IN535753572018-04-18
00842430105159Trios/OTS TRACTION EXTENSION SHORT5855-5785855-5782018-04-24
00842430105166Trios/OTS TRACTION EXTENSION LONG5855-1935855-1932018-04-26
00842430105357GM BOARD LEFT PAD5855-2875855-2872018-05-10
00842430105371GM BOARD RIGHT PAD5855-2865855-2862018-05-10
00842430105739Trios/OTS FOOT-END DRAPE HANGER POST5855-6175855-6172018-05-03
00842430105746Trios/OTS HEAD-END DRAPE HANGER POST5855-6155855-6152018-05-03
00842430105920PIVOTING ARM BOARD ASSY W/OUT PAD5362-65362-62018-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844107000804QuikBow Arbutus Medical IncKQZ2026-04-28
00848340016806ALLENHILL-ROM, INC.KQZ2026-04-24
00888867484986Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485099Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485105Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485112Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281521BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281491BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
00888867502710Arthrex®ARTHREX, INC.KQZ2025-08-14
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925Paradigm RevolutionConmed CorporationKQZ2023-06-13
20845854082932Paradigm RevolutionConmed CorporationKQZ2023-06-13
0078755101165490403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
00787551011678NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00816342020718Accessories, arthroscopicPARCUS MEDICAL LLCKQZ2022-12-06
00842331141027Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331143373Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331136627Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-10
00610570001712"100 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570001750"1500 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20