FDA.reportPublic FDA data

Hemorrhage Occluder Pin

Primary DI
00861838000309
Brand
Hemorrhage Occluder Pin
Company
TOOLS FOR SURGERY, LLC
Model
HOP-03
Catalog number
HOP-03
Device description
Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery.
Published
2019-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K040109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040109000HEMORRHAGE OCCLUDER PINTools For Surgery, LLC2004-03-25GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861838000309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861838000309008618380003098618380003090861838000309

GMDN Terms#

Term, Definition table
TermDefinition
Skin stapler/staple, non-bioabsorbableA sterile hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to approximate free edges of skin from an incision or wound. This stapler is a manually-powered device designed to mechanically deliver the staples; the staples are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Millimeter
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6314444448info@toolsforsurgery.com

Regulatory Flags#

DUNS number
841842441
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
00860013482107ZZIREN® Orogastric TubeZZ-GBT-32ZZ-GBT-322025-11-21
00860013482114ZZIREN® Orogastric TubeZZ-SGT-32ZZ-SGT-322025-11-21
00860013482121ZZIREN® Orogastric TubeZZ-GBT-36ZZ-GBT-362025-11-21
00860013482138ZZIREN® Orogastric TubeZZ-SGT-36ZZ-SGT-362025-11-21
00860013482145ZZIREN® Orogastric TubeZZ-GBT-40ZZ-GBT-402025-11-21
00860013482152ZZIREN® Orogastric TubeZZ-SGT-40ZZ-SGT-402025-11-21
00860002701387Circular Stapler Anvil Sizer SetANS-10ANS-102023-07-19
00860002701394Circular Stapler Head Sizer SetHSS-10HSS-102023-07-19
00860002701325Barbell Loop Ostomy DeviceBAR-2BAR-22023-07-17
00860002701349Barbell Loop Ostomy DeviceBAR-3BAR-32023-07-17
00860002701356Barbell Loop Ostomy DeviceBAR-4BAR-42023-07-17
00860002701363SIREN SGTSGT-36SGT-362023-07-17
00861838000330WIKI Drain, 15 Fr, 3 cm, 1 DrainWIK-15-3-1WIK-15-3-12023-07-17
00861838000347WIKI Drain, 15 Fr, 3 cm, 6 DrainsWIK-15-3-6WIK-15-3-62023-07-17
00860002701318Colorectal Air Syringe-OP EXALT-30EXALT-30EX2019-12-17
00860002701332Colorectal Air Syringe-LP EXALT-50EXALT-50EX2019-12-17
00861838000354Colorectal Air Syringe-OPALT-30ALT-302019-09-26
00861838000361Colorectal Air Syringe-LPALT-50ALT-502019-09-26
00861838000378Bariatric Air SyringeALT-BAALT-BA2019-09-26
00861838000316Hemorrhage Occluder Pin with ApplicatorHOP-APHOP-AP2019-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
16953886000033TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000040TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000057TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000064TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000071TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000088TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000095TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000101TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000330TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000347TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000354TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000408TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000415TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000422TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000439TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000446TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000453TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000460TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000477TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000484TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000491TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000514TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000521TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000569TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27