FDA.report

KMEDIC

Primary DI
24026704273274
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN014056
Catalog number
KM46917
Device description
SUTURE PASSER 9 1/4" CURVED WITH CROCHET HOOK
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWQPASSER

Product Code Classifications

CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704273270Direct MarkingGS10
24026704273274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704273270040267042732704026704273270
2402670427327424026704273274

GMDN Terms

TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a reusable device.

Device Sizes

TypeValueUnit
Length23.5Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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