FDA.reportPublic FDA data

itto

Primary DI
10818614022434
Brand
itto
Company
Maruho Medical, Inc.
Model
52-10120
Device description
Itto S+L shuttle and loop for use with itto CSP 20 in size 1 UHMWPE
Published
2021-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818614022434PackageGS18In Commercial Distribution
00818614022437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081861402243410818614022434
00818614022437008186140224378186140224370818614022437

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, single-useA cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117630237
Device count
1
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
false
Expiration date on label
true
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
10818614022595Disposable Punch, 6.5 mm 00-65P2022-09-15
10818614022649ABS Med Distraction PinMDS90914142023-08-29
10818614021406Distraction Screw909-122023-01-26
10818614021413Distraction Screw909-142023-01-26
10818614022601Distraction Pin, 12MM pouchSS-0088S2022-12-19
10818614022618Distraction Pin, 14MM pouchSS-0089S 2022-12-19
10818614022571Distraction Screw, 12MM pouchSM-00882022-09-01
10818614022588Distraction Screw, 14MM pouchSM-00892022-09-01
10818614020492Tri-Gate Disposable Cannula00-65702022-05-10
10818614020508Tri-Gate Disposable Cannula00-75702022-05-10
10818614020515Tri-Gate Disposable Cannula00-85702022-05-10
10818614020522Tri-Gate Disposable Cannula00-65902022-05-10
10818614020539Tri-Gate Disposable Cannula00-75902022-05-10
10818614020546Tri-Gate Disposable Cannula00-85902022-05-10
10818614021215Tri-Gate Notched Disposable Cannula00-857002022-05-10
10818614022489Galen Small Joint AnchorF-08-111062022-05-10
10818614022496Galen Small Joint AnchorF-08-111082022-05-10
10818614022526Kopis Knotless AnchorF-31-145202022-05-10
10818614022533Kopis Knotless AnchorF-31-155202022-05-10
10818614022540Kopis Knotless AnchorF-31-165202022-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857915007705STRATOS (Gen2)A.M. SURGICAL, INC.NBH2026-06-05
00857915007033RetraBE Single - Gen 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)A.M. SURGICAL, INC.NBH2026-06-04
00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
00857915007699Locking AttachmentA.M. SURGICAL, INC.NBH2026-05-20
07630345721204Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721211Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721228Surgical Manual InstrumentMedacta International SANBH2026-03-30
10080196385386MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385478MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392032MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392070MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392292MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385218MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-01-29
10845854026946DOUBLELATCHConmed CorporationNBH2023-12-05
10080196387984MedlineMEDLINE INDUSTRIES, INC.NBH2023-10-09
07630345778765Sports Med InstrumentsMedacta International SANBH2023-01-16
07630542702457Sports Med InstrumentsMedacta International SANBH2023-01-16
07613327379624NASTRYKER CORPORATIONNBH2022-12-06
10845854030387Hip Preservation System, PopLokConmed CorporationNBH2022-06-11
10845854028711CONMEDConmed CorporationNBH2021-10-14
10845854029893HIP PRESERVATION SYSTEM SIGNATURE SERIESConmed CorporationNBH2021-10-14
10845854017418Dry-DocConmed CorporationNBH2021-10-12
10845854017845Dry-DocConmed CorporationNBH2021-10-12
10845854018118CONMEDConmed CorporationNBH2021-10-12
10845854018408HEX FLEXConmed CorporationNBH2021-10-12
10845854018415HEX FLEXConmed CorporationNBH2021-10-12