LEEP REDIKIT

Primary DI
00888937000030
Brand
LEEP REDIKIT
Company
Coopersurgical, Inc.
Model
6061
Device description
LOOP Electrosurgical Excision Procedure (Contains Lidocaine with Epinephrine)
Published
2016-02-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
20888937000034PackageGS15In Commercial Distribution
00888937000030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893700003420888937000034
00888937000030008889370000308889370000300888937000030

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
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
60888937011199WallachCoopersurgical, Inc.HEE2016-09-21
20888937011207Wallach EndoBlock NeedleCoopersurgical, Inc.HEE2016-09-21
20888937011214Wallach EndoBlock NeedleCoopersurgical, Inc.HEE2016-09-21
20888937011191WallachCoopersurgical, Inc.HEE2016-09-21