FDA.report

LAP CHOLE PROCEDURE PACK

Primary DI
20607915136202
Brand
LAP CHOLE PROCEDURE PACK
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
GK128
Device description
Kit Contains: CA090, DIRECT DRIVE LCA 3/BX CTR33, 11X100 Kii OPT ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTR03, 5x100 Kii OPT ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX
Published
2015-10-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20607915136202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2060791513620220607915136202

GMDN Terms

TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags

DUNS number
187129135
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00607915146467Voyant Electrosurgical GeneratorEA0302026-01-16
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915140700Alexis® Orthopaedic ProtectorHR1002024-07-11
00607915114688Threaded Cannula and SealC05682016-09-24
10607915140325Alexis® O Wound Protector-RetractorC84062022-05-27
10607915145528Inzii Ripstop Redeployable Retrieval SystemCD0052024-03-19
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
10607915140790Voyant Maryland Fusion Device with Single-Step ActivationEB2122022-12-13
00607915140809Voyant Maryland Fusion Device with Single-Step ActivationEB2132022-12-13
10607915140813Voyant Maryland Fusion Device with Single-Step ActivationEB2142022-12-13
10607915145313GelPOINT V-Path C2B112023-03-17
10607915145320GelPOINT V-Path C2B122023-03-17
10607915145337GelPOINT V-Path C2B152023-03-17
10607915145344GelPOINT V-Path C2C112023-03-17
10607915145351GelPOINT V-Path C2C122023-03-17
10607915145368GelPOINT V-Path C2C152023-03-17
10607915146693GelPOINT V-Path C2B172023-03-17
00607915145613GelPOINT V-Path C2A172023-02-17
10607915141797Alexis® Contained Extraction SystemGTB142022-09-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
04251303822769BLUEENDOTROKAMED GmbHHET2026-03-03
04251303824961BLUEENDOTROKAMED GmbHHET2026-02-27
04251303824978BLUEENDOTROKAMED GmbHHET2026-02-27
00817401029130EndoplusEndoplusHET2026-02-06
00817401029123EndoplusEndoplusHET2026-01-16
00817401029116EndoplusEndoplusHET2025-12-19
00198506086892ELMED INCORPORATEDELMED INCORPORATEDHET2025-11-25
G465FG16000Non-ICG 5mm Laparoscope (0 Deg)Smartsurgn Inc.HET2025-08-27
G465FG17000Non-ICG 5mm Laparoscope (30 Deg)Smartsurgn Inc.HET2025-08-27
00198506044229ELMED INCORPORATEDELMED INCORPORATEDHET2025-08-15
00198506084256ELMED INCORPORATEDELMED INCORPORATEDHET2025-07-24
04048223128121Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
04048223128145Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
EAMIICT50100i-Cut Power SupplyAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50110i-CutAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50500i-Cut Power Supply Type AAMI Agency for Medical Innovations GmbHHET2025-05-05
00198506082542ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-30
00198506026096ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506026119ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027215ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027222ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00817401029109EndoplusEndoplusHET2025-04-10
00198506081330ELMED INCORPORATEDELMED INCORPORATEDHET2025-03-17
00817401029093EndoplusEndoplusHET2025-03-14