Wallach

Primary DI
20888937011191
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
OTC
false
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 kitA collection of sterile devices designed to deliver 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 gyneacological 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 consists of a procedural needle, syringe, catheter, and a filter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
60888937011199WallachCoopersurgical, Inc.HEE2016-09-21
20888937011207Wallach EndoBlock NeedleCoopersurgical, Inc.HEE2016-09-21
20888937011214Wallach EndoBlock NeedleCoopersurgical, Inc.HEE2016-09-21
00888937000030LEEP REDIKITCoopersurgical, Inc.HEE2016-02-02