FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KCHHook, Tracheal

Product Code Classifications

CodeDeviceSpecialtyClass
KCHHook, TrachealEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842209110360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209110360008422091103608422091103600842209110360

GMDN Terms

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

Regulatory Flags

DUNS number
832426782
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00842209138180NAR85-509285-50922026-03-24
00842209138197NAR85-509485-50942026-03-24
00842209138203NAR85-509585-50952026-03-24
00842209138210NAR80-197280-19722026-03-24
00842209138227NAR80-197380-19732026-03-24
00842209138234NAR77-013877-01382026-03-24
00842209138241NAR77-013977-01392026-03-24
00842209138258NAR77-014077-01402026-03-24
00842209138265NAR77-014177-01412026-03-24
00842209138272NAR77-014277-01422026-03-24

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