FDA.report

Henry Schein

Primary DI
00304040128602
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1004643
Catalog number
1004643
Device description
Curette Bone DE Lucas
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
EKECURETTE, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKECurette, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040128602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040128602003040401286023040401286020304040128602

GMDN Terms

TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

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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00304040187463Zirlux920004692000462026-02-04
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00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D928105106HDHFDLC0CURETTE MOLT 2/4HD, HF D/E DLCW.H. Holden, Inc.EKE2026-01-06
D928105109JHF59DLC0CURETTE BONE #9J HF D/E SHORT HANDLE DLCW.H. Holden, Inc.EKE2026-01-06
D928105113CH0SINUS CURETTE D/E GOLEC CHW.H. Holden, Inc.EKE2025-02-06
D928105159CH0SINUS CURETTE K-N OBTUSE SMITH CH D/EW.H. Holden, Inc.EKE2024-12-18
D928105102HDFE0CURETTE MOLT #2HD EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2024-12-17
D928105104HO0CURETTE MOLT #4HD H/O HANDLEW.H. Holden, Inc.EKE2024-12-17
D92810510524RCH0CURETTE MOLT 2CH / 4HD, RIGHT, CH D/EW.H. Holden, Inc.EKE2024-12-17
D9281051066HFDLC0MOLT 4 DULL LEFT / RIGHT CURETTE, DLC, ACCORDING TO DR. CHANW.H. Holden, Inc.EKE2024-12-17
D928105109SHD0BONE CURETTE #9, STRAIGHT, 3.15mm /3.75MM, D/E SERRATED HDW.H. Holden, Inc.EKE2024-12-17
D92810511501HD0SINUS CURETTE B-2 MINI - CUSTOM INSTRUMENT HDW.H. Holden, Inc.EKE2024-12-17
D92810510524LCH0CURETTE MOLT 2CH / 4HD, LEFT, CH D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916CH0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916HF0CURETTE MOLT #4HD HF HANDLE SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D928837102Z0BONE AUGMENTATION KIT ACC TO DR DANIEL CULLUMW.H. Holden, Inc.EKE2024-01-19
D928837151H0BONE TUNNELING KITW.H. Holden, Inc.EKE2024-01-19
D928837160H0LATERAL WINDOW SINUS CURETTE KIT ACC. TO DR. BART SILVERMANW.H. Holden, Inc.EKE2024-01-19
D9282007030ARNETT BONE CURETTEW.H. Holden, Inc.EKE2023-12-20
D9282007070ANTERIOR SINUS WALL CURETTEW.H. Holden, Inc.EKE2023-12-20
D928105102CH0CURETTE MOLT #2CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHE0CURETTE MOLT #2CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHFE0CURETTE MOLT #2CH EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2023-10-10
D928105102CHHF0CURETTE MOLT #2CH HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HD0CURETTE MOLT #2HD HD S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDE0CURETTE MOLT #2HD EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDF0CURETTE MOLT #2HD HD S/E FLAT TIPW.H. Holden, Inc.EKE2023-10-10
D928105102HDH0CURETTE MOLT #2HD HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CH0CURETTE MOLT #4CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHE0CURETTE MOLT #4CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHLAKE0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2023-10-10
D928105104HD0CURETTE MOLT #4HD HD S/EW.H. Holden, Inc.EKE2023-10-10