FDA.reportPublic FDA data

KMEDIC

Primary DI
44026704722318
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN013649
Catalog number
KM46188
Device description
PEDIATRIC CAST BREAKER 7"
Published
2024-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704722318Direct MarkingGS10
24026704268430PreviousGS10
14026704722317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4402670472231844026704722318
2402670426843024026704268430
1402670472231714026704722317

GMDN Terms#

Term, Definition table
TermDefinition
Cast breakerA manual surgical instrument with strong, curved blades used to grasp and break apart hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with curved serrated (serrated on the inside to provide grip) blades. These blades are prised between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create a grip on the plaster that can then be broken off in pieces. It is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Centimeter

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00190776424015MillenniumAvalign Technologies, Inc.HTD2026-08-27
00192896123632Adson Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-08-27
00190776419738MillenniumAvalign Technologies, Inc.HTD2026-08-25
00850088713596PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
00850088713619PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
04054462901821evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901852evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901869evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901876evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901883evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901890evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903405evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903450evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903467evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903504evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903573evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903597evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903603evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903634evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903641evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903658evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903665evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903672evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903740evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904129evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904143evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904235evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904273evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904310evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904358evonosevonos GmbH & Co. KGHTD2026-08-21