FDA.report

Hayden Medical

Primary DI
00840319750063
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
335-205A
Catalog number
335-205A
Device description
Hemorrhage Occluder Pin (Titanium), 1 each , individually packed sterile
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDWStaple, implantable

Product Code Classifications

CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840319750063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319750063008403197500638403197500630840319750063

GMDN Terms

TermDefinition
Skin stapler/staple, non-bioabsorbableA hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags

DUNS number
618214410
Device count
1
DM exempt
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319758571Hayden MedicalHM52501HM525012026-01-09
00840319758588Hayden MedicalHM52500-45/10HM52500-45/102026-01-09
00840319758595Hayden MedicalHM52500-45/5HM52500-45/52026-01-09
00840319758601Hayden MedicalHM52500-45HM52500-452026-01-09
00840319758533Hayden MedicalE1-1114E1-11142025-12-31
00840319758540Hayden MedicalE3-3646E3-36462025-12-31
00840319758557Hayden MedicalE3-2100E3-21002025-12-31
00840319758366Hayden MedicalE4-1532E4-15322025-12-24
00840319758373Hayden MedicalE4-1533E4-15332025-12-24
00840319758380Hayden MedicalE1-1084E1-10842025-12-24
00840319758397Hayden MedicalE5-6447TE5-6447T2025-12-24
00840319758403Hayden MedicalE3-2026E3-20262025-12-24
00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24
00840319758502Hayden Medical120-126D120-126D2025-12-24

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06946480503638Disposable Linear Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480510537Disposable Curved Cutter Staplers Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480563632Disposable Linear Staplers and ReloadsSinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480576052Disposable Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480576151Disposable Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589311Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589366Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589373Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
30705036040792ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
20705036040818ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
30705036040822ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
20705036040856ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10886874123642SureFormINTUITIVE SURGICAL, INC.GDW2025-06-20
24026704921724TELEFLEXTELEFLEX INCORPORATEDGDW2025-05-13
14026704921772TELEFLEXTELEFLEX INCORPORATEDGDW2025-05-13
34026704921783TELEFLEXTELEFLEX INCORPORATEDGDW2025-05-13
00850060791154AEONLEXINGTON MEDICAL, INC.GDW2025-05-01
00850060791130AEONLEXINGTON MEDICAL, INC.GDW2025-02-18
20884521827643EEACovidien LPGDW2025-02-07
20884521827650EEACovidien LPGDW2025-02-07
20884521827667EEACovidien LPGDW2025-02-07
00850060791109AEONLEXINGTON MEDICAL, INC.GDW2025-01-09
16925776112577easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112584easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112591easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112607easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
16925776112614easyCSTM Circular Stapler for Single UseEzisurg Medical Co., Ltd.GDW2025-01-07
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