FDA.reportPublic FDA data

QKit Procedure Tray

Primary DI
20888937000041
Brand
QKit Procedure Tray
Company
Coopersurgical, Inc.
Model
909074
Device description
For LOOP Electrosurgical Excision Procedure - contains Lidocaine with Epinephrine
Published
2016-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HGIElectrocautery, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935634000WALLACH LEEP PROCEDURE KITWallach Surgical Devices, Inc.1994-07-20HGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937000041PackageGS15In Commercial Distribution
00888937000047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893700004120888937000041
00888937000047008889370000478889370000470888937000047

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
false
Combination product
true
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
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113234407BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113234414BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236838BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236845BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236876BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236883BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236906BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236920BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236944BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236951BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236968BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236975BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236982BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236999BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237002BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237019BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237026BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237033BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237057BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
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10840113237095BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237125BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237149BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237156BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237163BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237170BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237187BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237194BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237200BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237217BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21