Wallach

Primary DI
60888937011199
Brand
Wallach
Company
Coopersurgical, Inc.
Model
920009
Device description
Endocervical Block Kit. Contents: 1 reinforced Luer Lock Needle, 1 18 gauge Luer Lock Needle and 1 Syringe with Finger Grips
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HEESet, Anesthesia, Paracervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEESet, Anesthesia, ParacervicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910253000LEEP REDIKITCooperSurgical, Inc.1991-04-18HEE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937011191PackageGS110In Commercial Distribution
60888937011199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893701119120888937011191
6088893701119960888937011199

GMDN Terms#

Term, Definition table
TermDefinition
Cervical anaesthesia needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument used to administer an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gynaecological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically includes connectors for attachment to the piston of a syringe or intravascular administration set. This is a single-use device.

Regulatory Flags#

DUNS number
801895244
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20888937010927Potocky Needle®Coopersurgical, Inc.HEE2016-09-28
20888937010934Potocky Needle®Coopersurgical, Inc.HEE2016-09-28
10885403143243N/ACAREFUSION 2200, INCHEE2016-09-23
10885403143250N/ACAREFUSION 2200, INCHEE2016-09-23
10885403143267N/ACAREFUSION 2200, INCHEE2016-09-23
50885403143241N/ACAREFUSION 2200, INCHEE2016-09-23
50885403143265N/ACAREFUSION 2200, INCHEE2016-09-23
50885403143258N/ACAREFUSION 2200, INCHEE2016-09-23
20888937011207Wallach EndoBlock NeedleCoopersurgical, Inc.HEE2016-09-21
20888937011214Wallach EndoBlock NeedleCoopersurgical, Inc.HEE2016-09-21
20888937011191WallachCoopersurgical, Inc.HEE2016-09-21
00888937000030LEEP REDIKITCoopersurgical, Inc.HEE2016-02-02