FDA.reportPublic FDA data

NAR Tracheal Hook

Primary DI
00842209110360
Brand
NAR Tracheal Hook
Company
NORTH AMERICAN RESCUE, LLC
Model
10-0020
Catalog number
10-0020
Device description
NAR Tracheal Hook
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCHHook, Tracheal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCHHook, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842209110360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209110360008422091103608422091103600842209110360

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, single-useA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209139255NAR Kit10-010310-01032026-07-06
00842209139262NAR85-515685-51562026-07-06
00842209139279NAR85-516985-51692026-07-06
00842209139286NAR80-0159-TLS80-0159-TLS2026-07-06
00842209139293NAR80-146180-14612026-07-06
00842209122691NAR85-12972022-12-08
00842209123926NAR80-09232022-12-08
00842209139149NAR10-000810-00082026-06-22
00842209139156NAR10-000910-00092026-06-22
00842209139163NAR10-001010-00102026-06-22
00842209139170NAR10-001110-00112026-06-22
00842209139187NAR10-001210-00122026-06-22
00842209139194NAR10-001310-00132026-06-22
00842209139200NAR10-001410-00142026-06-22
00842209139231NAR80-156280-15622026-06-22
00842209139248NAR85-515385-51532026-06-22
00842209138760NAR77-014377-01432026-05-27
00842209138777NAR77-014477-01442026-05-27
00842209138784NAR77-014577-01452026-05-27
00842209138791NAR77-014677-01462026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613031459MSI Precision Specialty InstrumentsMed Saver, Inc.KCH2025-08-01
04049047041801GimmiGimmi GmbHKCH2025-05-08
04049047014348GimmiGimmi GmbHKCH2025-04-24
04049047038078GimmiGimmi GmbHKCH2025-04-24
00887482058640Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KCH2024-08-07
00840183513825BR Surgical, LLCBR Surgical, LLCKCH2024-06-10
00190776390204MillenniumAvalign Technologies, Inc.KCH2024-05-31
00190776388997MillenniumAvalign Technologies, Inc.KCH2024-05-16
G043280300BEARBear-Ent, LLCKCH2024-04-25
00888515035676BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035690BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035706BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035720BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035737BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035744BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035751BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
G586G93151250Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
G586G93151260Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
00190776045661AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045678AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045777AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223892AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223939AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776321413MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321437MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321468MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321505MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321512MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
G2231336220Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKCH2023-08-23