FDA.reportPublic FDA data

Flexor Tendon Sheath Retractor and Suture Retriever / Sheath Dilator

Primary DI
00816101010004
Brand
Flexor Tendon Sheath Retractor and Suture Retriever / Sheath Dilator
Company
TOBY ORTHOPAEDICS
Model
NA
Catalog number
TO-FTRT
Device description
The Flexor Tendon Sheath Retractor and Suture Retriever/ Sheath Dilator device, also referred to as the FTRT device, includes a sheath dilator tool and a transparent funnel-sheath retractor tool, that are to be used in surgical procedures that aim to repair lacerated digital flexor tendons.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GADRetractor
HWQPasser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
HWQPasserOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816101010004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816101010004008161010100048161010100040816101010004

GMDN Terms#

Term, Definition table
TermDefinition
Tendon approximatorOne of a pair or set of surgical instruments used to grasp the torn or resected portions of a tendon to hold the portions in apposition for the purpose of reattaching one portion to the other in order to repair the structure. Also, an instrument used to grasp a tendon, or separated parts of a tendon, to position it in a surgical opening. This is a reusable device.

Regulatory Flags#

DUNS number
024163331
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816101017973Cannulated Cruciform Driver with Quick ConnectNATO-DRI-CQCCR2026-04-21
00816101011933WOLF Plate, 70mm, 5 HoleNATO-LBP-0702020-08-15
00816101011940WOLF Plate, 96mm, 7 HoleNATO-LBP-0962020-08-15
00816101011957WOLF Plate, 122mm, 9 HoleNATO-LBP-1222020-08-15
00816101011964WOLF Plate, 148mm, 11 HoleNATO-LBP-1482020-08-15
00816101011971WOLF Plate, 174mm, 13 HoleNATO-LBP-1742020-08-15
00816101011988WOLF Plate, 200mm, 15 HoleNATO-LBP-2002020-08-15
00816101011995WOLF Plate, 226mm, 17 HoleNATO-LBP-2262020-08-15
00816101012008WOLF Plate, 252mm, 19 HoleNATO-LBP-2522020-08-15
00816101012015WOLF Plate, 278mm, 21 HoleNATO-LBP-2782020-08-15
00816101012022WOLF Low Profile Plate, 70mm, 5 HoleNATO-LP-LBP-0702020-08-15
00816101012039WOLF Low Profile Plate, 96mm, 7 HoleNATO-LP-LBP-0962020-08-15
00816101012046WOLF Low Profile Plate, 122mm, 9 HoleNATO-LP-LBP-1222020-08-15
00816101012053WOLF Low Profile Plate, 148mm, 11 HoleNATO-LP-LBP-1482020-08-15
00816101012060WOLF Curved Low Profile Plate, 174mm, 13 HoleNATO-CLP-LBP-1742020-08-15
00816101012077WOLF Curved Low Profile Plate, 200mm, 15 HoleNATO-CLP-LBP-2002020-08-15
00816101012084WOLF Curved Low Profile Plate, 226mm, 17 HoleNATO-CLP-LBP-2012020-08-15
00816101010257PANTERA PLATE, LEFT, 73mmNATO-PHP-L732020-08-13
00816101010264PANTERA PLATE, RIGHT, 73mmNATO-PHP-R732020-08-13
00816101010271PANTERA PLATE, LEFT, 83mmNATO-PHP-L832020-08-13

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Primary DI, Brand, Company table
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08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
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