FDA.reportPublic FDA data

KMEDIC

Primary DI
14026704722294
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN013641
Catalog number
KM46133
Published
2023-10-13
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
LGGINSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704722295Direct MarkingGS10
24026704268324PreviousGS10
14026704722294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4402670472229544026704722295
2402670426832424026704268324
1402670472229414026704722294

GMDN Terms#

Term, Definition table
TermDefinition
Cast spreader, reusableA hand-operated instrument with specially designed blades intended to separate and spread hardened plaster, i.e., plaster that has already formed a cast around a patient's limb or body part. It is designed like large forceps with flat, outer-edge serrated blades that may be exchangeable and which are wedge-shaped (thin at the working end). The blades are intended to be prised between cut plaster so that when the device handles are squeezed the cast separates. It is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22.5Centimeter

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421526MillenniumAvalign Technologies, Inc.LGG2026-05-05
00810058670533Professional Surgical Instruments Co., Inc. Professional Surgical Instruments Co., Inc.LGG2026-02-12
00194613087906MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-08-01
04049047005001GimmiGimmi GmbHLGG2025-04-02
00194613008345MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-03-21
00840306823039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LGG2025-01-17
00887482044421Symmetry Wolff-BoehlerASPEN SURGICAL PRODUCTS, INC.LGG2024-08-15
00887482054772Symmetry Wolfe-BoehlerASPEN SURGICAL PRODUCTS, INC.LGG2024-08-15
00887482037287Symmetry WaltonASPEN SURGICAL PRODUCTS, INC.LGG2024-08-12
00840183517687BR Surgical, LLCBR Surgical, LLCLGG2024-03-14
00840183505738BR Surgical, LLCBR Surgical, LLCLGG2024-03-13
00888515326071BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
00888515326088BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
14026704722300KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
44026704722301KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
00840183521196BR Surgical, LLCBR Surgical, LLCLGG2024-02-06
G586N5166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166370Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166480Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95171160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95174160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95177160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95182410Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95192310Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
00842331194016Novo Surgical Inc. NOVO SURGICAL, INC.LGG2023-12-07
44026704722295KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
00190776283667AvalignAvalign Technologies, Inc.LGG2023-09-28
00840183502652BR Surgical, LLCBR Surgical, LLCLGG2023-05-26
00842962122174HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29