FDA.report

Henry Schein

Primary DI
20304040154124
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702698
Catalog number
5702698
Device description
Needle Disposable Safety 21Gx1.5
Published
2021-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040154124PackageGS18In Commercial Distribution
10304040154127PrimaryGS10
00304040154120Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404015412420304040154124
1030404015412710304040154127
00304040154120003040401541203040401541200304040154120

GMDN Terms

TermDefinition
Mobile orthovoltage therapeutic x-ray systemAn assembly of devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of skin cancer (e.g., basal cell or squamous cell carcinoma) or other skin conditions (e.g., psoriasis, keloid). The radiation source typically uses a tube voltage of between approximately 100 kV and 500 kV and will be used in conjunction with a variety of topical applicators. The main system is mobile (on wheels) and is typically used in a radiotherapy suite or other clinical setting.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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