FDA.reportPublic FDA data

RAZEK EQUIPAMENTOS

Primary DI
07898994583424
Brand
RAZEK EQUIPAMENTOS
Company
RAZEK EQUIPAMENTOS LTDA
Model
742680000
Device description
Razek Suture Passer Hook
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898994583424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898994583424078989945834247898994583424

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898213154
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07908832573699RAZEK EQUIPAMENTOS7345900002024-12-06
07908832580888RAZEK EQUIPAMENTOS7321700032024-12-06
07908832572333RAZEK EQUIPAMENTOS7311000002024-12-05
07908832572340RAZEK EQUIPAMENTOS7311000012024-12-05
07908832572418RAZEK EQUIPAMENTOS7311400002024-12-05
07908832572425RAZEK EQUIPAMENTOS7311400012024-12-05
07908832572432RAZEK EQUIPAMENTOS7342100002024-12-05
07908832572449RAZEK EQUIPAMENTOS7342101002024-12-05
07908832572456RAZEK EQUIPAMENTOS7342200002024-12-05
07908832572463RAZEK EQUIPAMENTOS7342201002024-12-05
07908832572470RAZEK EQUIPAMENTOS7311500002024-12-05
07908832572487RAZEK EQUIPAMENTOS7311500012024-12-05
07908832572494RAZEK EQUIPAMENTOS7311600002024-12-05
07908832572500RAZEK EQUIPAMENTOS7311600012024-12-05
07908832572555RAZEK EQUIPAMENTOS7311900002024-12-05
07908832572562RAZEK EQUIPAMENTOS7311900012024-12-05
07908832572579RAZEK EQUIPAMENTOS7342300002024-12-05
07908832572586RAZEK EQUIPAMENTOS7342301002024-12-05
07908832572593RAZEK EQUIPAMENTOS7342400002024-12-05
07908832572609RAZEK EQUIPAMENTOS7342401002024-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
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