FDA.reportPublic FDA data

Hemorrhage Occluder Pin with Applicator

Primary DI
00868742000104
Brand
Hemorrhage Occluder Pin with Applicator
Company
SURGIN SURGICAL INSTRUMENTATION, INC.
Model
CR1007
Catalog number
CR1007
Device description
Hemorrhage Occluder Pin Standard - 10 mm head
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890447000HEMORRHAGE OCCLUDORSurgeon Surgical Instrumentation, Inc.1989-02-23GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10868742000101PackageGS12In Commercial Distribution
00868742000104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086874200010110868742000101
00868742000104008687420001048687420001040868742000104

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhage control pinA thumbtack-like implant typically intended to be used during pelvic surgery to control severe, localized bleeding from veins in the presacral area. It is implanted through a presacral vein into the sacrum (fused vertebral bones of the lower spine) after other methods of haemostasis (e.g., cauterization, suturing, clamping) have been determined ineffective. The device is made of metal [e.g., titanium (Ti)], having a large disk-like head and a serrated shaft. It may be attached to a disposable pin applicator that helps the surgeon position it prior to pressing it into place.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007537400surginhop@mpwus.com

Regulatory Flags#

DUNS number
076656164
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000610088ReleveGY1530GY15302023-07-27
00850000610156ReleveGY1500/BX5GY1500/BX52023-07-27
00850000610071ReleveGY1500GY15002023-07-15
00850000610002DoseRiteDRJ05AT-6DRJ05AT-62023-07-10
00850000610026DoseRiteDRJ05AT-6/BX10DRJ05AT-6/BX102023-07-10
00850000610033DoseRiteDRJ05AT-6MDRJ05AT-6M2023-07-10
00850000610064DoseRiteDR0084NL-12DR0084NL-122023-07-10
00850000610118DoseRiteDR-AIN01-USDR-AIN01-US2023-07-10
00868742000128Salgado DriverCR2000CR20002023-06-12
00868742000135Salgado DriverCR2005CR20052023-06-12
00868742000111Hemorrhage Occluder Pin with ApplicatorCR1014CR10142015-10-20

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Primary DI, Brand, Company table
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