FDA.report

Marina Medical

Primary DI
00840306808289
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
350-252
Catalog number
350-252
Device description
McCall Uterosacral Pedical Clamp
Published
2022-11-07
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
HGCCLAMP, UTERINE

Product Code Classifications

CodeDeviceSpecialtyClass
HGCClamp, UterineObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306808289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306808289008403068082898403068082890840306808289

GMDN Terms

TermDefinition
Pelvic C-clampA manual surgical instrument designed as an emergency stabilization device for unstable injuries and fractures of the pelvic ring; these conditions can be associated with massive blood loss and terminal shock. It is mechanically fixed to either side of the pelvis by means of thick nails permitting quick and efficient compression and stabilization of pelvic fractures and luxations providing time for haemorrhage and embolization control. It is typically designed as a C-shaped frame with a rail, twin adjustable arms, adjusting side screws, and nails made of high-grade stainless steel and/or synthetic material. It is compatible for use in computed tomography (CT). 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

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00840306837227Marina Medical1570-BR21570-BR22025-08-08
00840306837234Marina Medical1570-BR31570-BR32025-08-08
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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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