FDA.report

LAP CHOLE KIT

Primary DI
30607915133307
Brand
LAP CHOLE KIT
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
K2650
Device description
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFF12, 5x100 Kii® Fios® ADVFIX DP 10/BX
Published
2015-10-16
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

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30607915133307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3060791513330730607915133307

GMDN Terms

TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. 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
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00846159038644SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038651SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038668SCANLAN® InstrumentsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038675SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038682SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038699SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038705SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038712SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038729SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11