FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704291933
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015709
Catalog number
KM69827
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXDCLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704291939Direct MarkingGS10
24026704291933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704291939040267042919394026704291939
2402670429193324026704291933

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA surgical instrument designed to grasp and hold a bone during a surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9017971000Surgical DirectSurgical Direct, Inc.HXD2026-08-21
00190776426606MillenniumAvalign Technologies, Inc.HXD2026-08-19
00840277133779Innomed, Inc.INNOMED, INC.HXD2026-08-18
00840277133786Innomed, Inc.INNOMED, INC.HXD2026-08-18
05060624127007CS Mayfield / Doro AdaptorsCARE SURGICAL LIMITEDHXD2026-08-07
00190776405786MillenniumAvalign Technologies, Inc.HXD2026-07-24
04058749047981NAFehling Instruments GmbH & Co. KGHXD2026-07-17
B8034503260ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503660ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503700ORTHOMEDORTHO-MED, INC.HXD2026-07-14
00840277133656Innomed, Inc.INNOMED, INC.HXD2026-05-29
ESAM3840131STOMA®Storz am Mark GmbHHXD2025-04-30
ESAM3841131STOMA®Storz am Mark GmbHHXD2025-04-30
00840314269690gSourceGSOURCE LLCHXD2025-01-15
00840314269591gSourceGSOURCE LLCHXD2024-08-14
10840199539571Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539588Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539595Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539601Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539618Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539625Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539632Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539649Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199535894ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535948Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535955Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535979Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536013Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536020Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536037Aortic ClampKOROS U.S.A., INC.HXD2024-01-31