FDA.reportPublic FDA data

Cervical Dilator Set

Primary DI
60888937017740
Brand
Cervical Dilator Set
Company
Coopersurgical, Inc.
Model
64-372
Device description
Cervical Dilator Set- Small (set of 6)
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
HHMSound, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60888937017740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088893701774060888937017740

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, reusableA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length318Millimeter

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
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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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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613017545MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613085841MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613111083MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00190776405670MillenniumAvalign Technologies, Inc.HHM2025-07-18
00190776405687MillenniumAvalign Technologies, Inc.HHM2025-07-18
05010058179585InstrapacROBINSON HEALTHCARE LIMITEDHHM2025-05-21
04049047064725GimmiGimmi GmbHHHM2025-05-20
04049047064923GimmiGimmi GmbHHHM2025-05-20
04049047045267GimmiGimmi GmbHHHM2025-05-14
04049047045328GimmiGimmi GmbHHHM2025-05-14
00190776394882MillenniumAvalign Technologies, Inc.HHM2025-05-08
00190776393175MillenniumAvalign Technologies, Inc.HHM2025-05-05
00194613033750MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613082673MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613087029MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613099855MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00190776388270MillenniumAvalign Technologies, Inc.HHM2024-11-13
05060212057563Sims Uterine SoundDTR MEDICAL LIMITEDHHM2024-10-14
10841742149124HNM MEDICALHNM STAINLESS, LLC.HHM2024-08-30
00190776384906MillenniumAvalign Technologies, Inc.HHM2024-08-26
00840343722890GEN2SURGIX MEDICAL LLCHHM2024-06-28
00840183525828BR Surgical, LLCBR Surgical, LLCHHM2024-06-04
00810123207183Adler Instrument CompanyAdler, Inc.HHM2024-05-10
04719894432854Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HHM2024-04-08
00840343721978GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840343721985GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840183507121BR Surgical, LLCBR Surgical, LLCHHM2024-03-15
00840183506322BR Surgical, LLCBR Surgical, LLCHHM2024-03-13
00840183506384BR Surgical, LLCBR Surgical, LLCHHM2024-01-30
GYNX43340GynexGYNEX CORPORATIONHHM2023-12-19