FDA.reportPublic FDA data

DR. AZAR LAP CHOLE PACK

Primary DI
30607915133994
Brand
DR. AZAR LAP CHOLE PACK
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
K2703
Device description
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30607915133994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3060791513399430607915133994

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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#

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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

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Primary DI, Brand, Company table
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00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
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00846159038675SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
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00846159038699SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
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