FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704268430
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN013649
Catalog number
KM46188
Device description
"PEDIATRIC CAST BREAKER 7"""
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
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704268436Direct MarkingGS10
24026704268430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704268436040267042684364026704268436
2402670426843024026704268430

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
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902167344ARROWIPN916986CA-22123-F2026-07-30
10801902190908ARROWIPN919754CC-04100-S2026-07-30
10801902192933ARROWIPN920077CDA-25122-U1A2026-07-30
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902193527ARROWIPN920130CS-15242-SPM2026-07-30
10801902193619ARROWIPN920140CS-15232-VFIM2026-07-30
10801902193626ARROWIPN920141CS-15232-VF2026-07-30
10801902193633ARROWIPN920142CS-15232-VFM2026-07-30
10801902193688ARROWIPN920131CS-15282-SPM2026-07-30
10801902194463ARROWIPN920404CS-15232-VFI2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30
10801902197716ARROWIPN920778JC-05400-E2026-07-30
10801902198461ARROWIPN920836PW-18080-HN2026-07-30
10801902200768ARROWIPN921145CL-078352026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277133724Innomed, Inc.INNOMED, INC.HTD2026-07-29
B382SD92022614E0Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9203561000Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9206011020Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B3825SD918621130Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493210Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493220Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493230Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD91849612000Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9185741000Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9185911000Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9185921000Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9185941090Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9186281000Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9186411010Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918650030Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9187101000Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918731100Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD9187311000Surgical DirectSurgical Direct, Inc.HTD2026-07-28
00192896123571Adson Needle Holding ForcepsSONTEC INSTRUMENTS, INC.HTD2026-07-27
00190776422035MillenniumAvalign Technologies, Inc.HTD2026-07-24
B382SD9141551000Surgical DirectSurgical Direct, Inc.HTD2026-07-24
00850088713183PRINCETONPrinceton Medical Group, Inc.HTD2026-07-23
B382SD9017971040Surgical DirectSurgical Direct, Inc.HTD2026-07-23
B382SD9029931060Surgical DirectSurgical Direct, Inc.HTD2026-07-23
00190776400460MillenniumAvalign Technologies, Inc.HTD2026-07-21
00190776395360MillenniumAvalign Technologies, Inc.HTD2026-07-14
B382SD906201100Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD906202100NC0Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD91705515T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13