FDA.report

Marina Medical

Primary DI
00840306806780
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
280-801
Catalog number
280-801
Device description
Simple IUD Hook, Malleable, 4mm, 25.5cm
Published
2022-11-08
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
HHFREMOVER, INTRAUTERINE DEVICE, CONTRACEPTIVE, HOOK-TYPE

Product Code Classifications

CodeDeviceSpecialtyClass
HHFRemover, Intrauterine Device, Contraceptive, Hook-TypeObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306806780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306806780008403068067808403068067800840306806780

GMDN Terms

TermDefinition
Intrauterine device removal hook, reusableA hand-held manual instrument intended to be used by a physician for the extraction of an intrauterine device (IUD). The proximal end forms a handle which may vary in shape and which tapers toward the distal end to form a hook. It is typically made of high-grade stainless steel. This is a reusable 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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00840306837227Marina Medical1570-BR21570-BR22025-08-08
00840306837234Marina Medical1570-BR31570-BR32025-08-08
00840306837241Marina Medical1570-BR51570-BR52025-08-08
00840306837258Marina Medical1570-BR61570-BR62025-08-08
00840306837265Marina Medical1570-BR101570-BR102025-08-08
00840306837180Marina Medical110-346110-3472025-07-02
00840306837197Marina Medical110-347110-3472025-07-02
00840306837173Marina Medical050-964050-9642025-06-04
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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00842331164248Novo Surgical Inc. NOVO SURGICAL, INC.HHF2022-11-13
00842331152047Novo Surgical Inc. NOVO SURGICAL, INC.HHF2022-11-12
00842331146190Novo Surgical Inc. NOVO SURGICAL, INC.HHF2022-11-11
00840306806797Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HHF2022-11-07
00888937019667Double IUD ExtractorCoopersurgical, Inc.HHF2022-10-30