FDA.report

Henry Schein

Primary DI
00304040128985
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1008745
Catalog number
1008745
Device description
Hemostat Kelly 5-1/2" Straight
Published
2020-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMDHEMOSTAT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040128985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040128985003040401289853040401289850304040128985

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
false
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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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
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00840343725884GEN2SURGIX MEDICAL LLCEMD2025-03-07
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00842517112209Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
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