FDA.report

DR. ARMSTRONG LAP CHOLE

Primary DI
30607915134342
Brand
DR. ARMSTRONG LAP CHOLE
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
K2735
Device description
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFB03, 5x100 Kii® SH BLD ADVFIX, 6/BX CFB73, 12x100 Kii® SH BLD ADVFIX 6/BX C4120, 38CM GRASPER REPOS CART, 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
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30607915134342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3060791513434230607915134342

GMDN Terms

TermDefinition
Rigid endoscopic grasping forceps, single-useA sterile, rigid manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument. It is typically made of metal and plastic materials and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. 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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