FDA.report

Marina Medical

Primary DI
00840306806995
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
290-910
Catalog number
290-910
Device description
Jackson Biopsy Punch 2mm x 30cm
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HFBFORCEPS, BIOPSY, GYNECOLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306806995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306806995008403068069958403068069950840306806995

GMDN Terms

TermDefinition
Skin-coring punch, single-useA hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically made of high-grade stainless steel and is available in various cutting head sizes; it is not a biopsy gun. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags

DUNS number
011442279
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00840306837265Marina Medical1570-BR101570-BR102025-08-08
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00840306837197Marina Medical110-347110-3472025-07-02
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00840306805882Marina MedicalR642.07R642.072025-04-04
00840306812026Marina Medical180-140180-1402025-03-12
00840306830938Marina Medical20-017020-01702025-03-12
00840306830945Marina Medical20-017420-01742025-03-12
00840306836466Marina Medical200-262200-2622025-03-07

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