FDA.report

KIT LAPAROSCOPIA-CIMA

Primary DI
30607915129010
Brand
KIT LAPAROSCOPIA-CIMA
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
K2284
Device description
Kit Contains: C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTR12, 5x100 Kii® OPT ZTHR DP 10/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX C4150, 5x38cm EPIX® INLINE GRASPER 10/BX CB050, 5x38cm EPIX® INLINE SCISSORS 10/BX CY050, 5x38cm EPIX® INLINE DISSCT 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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30607915129010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3060791512901030607915129010

GMDN Terms

TermDefinition
Laparoscopic electrosurgical blunt dissectorA sterile, rigid, laparoscopic device, covered with a sheath of electrical insulation, designed to perform through a compatible laparoscopic instrument (e.g., an access port) and to be connected to an electrosurgical diathermy generator when required to provide electrical current, to facilitate blunt dissection (e.g., hernia repair, cholecystectomy, colectomy) between tissue planes accessible via the abdominal cavity. It is a monopolar device typically constructed as a long insulated metal instrument whose distal end is equipped with a stainless steel scissors-like tip of various configurations operated through scissors-like ring handles at the proximal end. 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

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10607915145313GelPOINT V-Path C2B112023-03-17
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