FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306837289
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
33727-17
Catalog number
33727-17
Device description
Doyen Periosteal Elevator, Curved LEFT for Right Hand, 17cm
Published
2025-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306837289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306837289008403068372898403068372890840306837289

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length17Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags#

DUNS number
011442279
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840306837401Marina Medical190-224190-2242026-07-21
00840306817755Marina Medical110-691LS110-691LS2024-03-20
00840306837388Marina Medical200-281200-2812026-05-11
00840306837395Marina Medical200-280200-2802026-05-11
00840306811586Marina Medical110-671L110-671L2024-01-30
00840306811654Marina Medical110-689L110-689L2024-01-30
00840306811661Marina Medical110-800110-8002024-01-30
00840306837364Marina Medical050-182CER050-182CER2026-04-15
00840306837371Marina Medical050-701CER050-701CER2026-04-15
00840306837272Marina Medical33725-1733725-172025-09-03
00840306837333Marina Medical99-76099-7602026-02-18
00840306837340Marina Medical050-335SCE050-335SCE2026-02-18
00840306837357Marina Medical050-472SCE050-472SCE2026-02-18
00840306824579Marina Medical222-222222-2222024-05-01
00840306835919Marina Medical800-935800-9352024-12-10
00840306835940Marina Medical800-943800-9432024-12-11
00840306835933Marina Medical800-941800-9412024-10-22
00840306835551Marina Medical800-400-05800-400-052024-10-11
00840306834479Marina Medical521-055521-0552024-09-19
00840306834516Marina Medical522-055522-0552024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423704MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423711MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423728MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424374MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424381MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424398MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776422653MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422660MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422684MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422462MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422523MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422585MillenniumAvalign Technologies, Inc.LRC2026-07-31
09348811102645INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
09348811102669INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093777ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321070Surgical DirectSurgical Direct, Inc.LRC2026-07-29
00190776422080MillenniumAvalign Technologies, Inc.LRC2026-07-28
00198506092442ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092633ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092664ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092763ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092787ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092824ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093043ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093050ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28