Potocky Needle®

Primary DI
20888937010934
Brand
Potocky Needle®
Company
Coopersurgical, Inc.
Model
6166
Device description
Potocky Needle® For Intra Cervical Block
Published
2016-09-28
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
K910252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910252000POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLECooperSurgical, Inc.1991-03-04HEE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937010934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893701093420888937010934

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
No natural rubber latex
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
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
00888937000030LEEP REDIKITCoopersurgical, Inc.HEE2016-02-02