FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704291728
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015690
Catalog number
KM69622
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
HTSKNIFE, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704291724Direct MarkingGS10
24026704291728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704291724040267042917244026704291724
2402670429172824026704291728

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.

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
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
00192896122796McIlwraith Bistouri KnifeSONTEC INSTRUMENTS, INC.HTS2026-03-10
00853508002645BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-02-16
00840967154527SigmaALPHATEC SPINE, INC.HTS2025-07-23
00192896121560Arthroscopic Bayonet KnifeSONTEC INSTRUMENTS, INC.HTS2025-05-14
10888277392687MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-04-17
00853508002621BESTLacey Manufacturing Company, LLCHTS2025-03-25
10080196392582MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-22
10080196392636MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392643MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392667MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392564MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392571MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392588MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392595MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392601MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392618MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392625MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392632MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392649MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392656MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392663MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392670MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392694MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392700MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392717MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392724MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392575MEDLINE RENEWALMEDLINE INDUSTRIES, INC.HTS2025-02-11
00843575121219b-ONE Hip SpecialtyB-ONE ORTHO, CORP.HTS2025-01-22
08800147701097Target Endoscopic InstrumentSOLENDOS Inc.HTS2024-12-09