FDA.reportPublic FDA data

Novak Curette

Primary DI
00888937016932
Brand
Novak Curette
Company
Coopersurgical, Inc.
Model
64-626
Device description
Novak Curette
Published
2022-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937016932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937016932008889370169328889370169320888937016932

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial biopsy curetteA hand-held, surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. It is typically made of high-grade stainless steel and is available in a variety of designs: 1) a long, thin, instrument with very small spoon-like scoop terminating at either end and a centrally placed handle; 2) a long, thin tubular device with a serrated opening at the distal end and a connection to a suction device or a syringe at the proximal end; or 3) a single-ended device with a scraper at the distal end. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length248Millimeter
Outer Diameter2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company#

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60888937029798ORIGIO Gradient 90 w/o Gentamicin 84905060D2026-03-12
00888937028331ORIGIO Sequential Blast83050010M2026-02-05
00888937028348ORIGIO Sequential Blast83050060M2026-02-05
00888937028355ORIGIO Sequential Blast83060010M2026-02-05
00888937028386ORIGIO Sequential Cleav83030010M2026-02-05
00888937028393ORIGIO Sequential Cleav83030060M2026-02-05
00888937028409ORIGIO Sequential Cleav83040010M2026-02-05
00888937028416ORIGIO Sequential Cleav83040060M2026-02-05
00888937028430ORIGIO Sequential Fert83010010M2026-02-05
00888937028447ORIGIO Sequential Fert83010060M2026-02-05
00888937028454ORIGIO Sequential Fert83020010M2026-02-05
00888937028461ORIGIO Sequential Fert83020060M2026-02-05
00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
00888937028973Origio Handling83110060M83112026-02-05
00888937028980Origio Handling83110125M83112026-02-05
00888937029116SAGE 1-Step67010010M2026-02-05
00888937029123SAGE 1-Step67010060M2026-02-05
60888937029330ORIGIO Sperm Wash84050060M2026-02-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04052536215539tezoUlrich GmbH & Co. KGFZS2026-03-16
04052536215546tezoUlrich GmbH & Co. KGFZS2026-03-16
00810130207367MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207374MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207381MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207398MSIModern Surgical Instruments LLCFZS2026-03-12
04052536017560tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017577tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017584tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017751tezoUlrich GmbH & Co. KGFZS2026-03-12
00810158219182PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
00810158219199PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
M93071015043SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
M93071015044SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
00810158218802PRINCETONPrinceton Medical Group, Inc.FZS2026-02-05
04059453143389Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZS2026-02-02
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00810158218598PRINCETONPrinceton Medical Group, Inc.FZS2026-01-16
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00810158218505PRINCETONPrinceton Medical Group, Inc.FZS2026-01-15
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