FDA.report

Henry Schein

Primary DI
00304040023129
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1048387
Catalog number
1048387
Device description
Forceps Drssing Serrated
Published
2019-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040023129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040023129003040400231293040400231290304040023129

GMDN Terms

TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is typically metallic and available in various sizes. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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00198506091124ELMED INCORPORATEDELMED INCORPORATEDGEN2026-05-26
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00846159039337SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039344SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039351SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039382SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039399SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039405SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039429SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039436SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039443SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039450SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039474SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039504SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039528SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039535SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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