FDA.reportPublic FDA data

Quinelato

Primary DI
07898506816095
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QW.500.16
Catalog number
QW.500.16
Device description
Quinelato needle holder wire 16cm
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506816095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506816095078985068160957898506816095

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
899060826
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899798207462QuinelatoQD.938.102025-02-27
07899798207721QuinelatoQD.310.032025-02-27
07899798208858QuinelatoQX.926.182025-02-27
07899798208865QuinelatoQX.923.162025-02-27
07899798208872QuinelatoQX.922.222025-02-27
07899798208216QuinelatoQN.950.15QN.950.152025-01-03
07899798208223QuinelatoQX.927.00QX.927.002025-01-03
07899798208230QuinelatoQX.927.01QX.927.012025-01-03
07899798208247QuinelatoQX.924.19QX.924.192025-01-03
07899798208254QuinelatoQX.925.24QX.925.242025-01-03
07899798208261QuinelatoQX.921.19QX.921.192025-01-03
07899798208278QuinelatoQX.920.19QX.920.192025-01-03
07898506850297QuinelatoQO.996.03QO.996.032023-07-05
07899798207509QuinelatoQD.721.15QD.721.152024-04-15
07899798207530QuinelatoQD.724.25QD.724.252024-04-15
07899798207547QuinelatoQD.725.30QD.725.302024-04-15
07899798207585QuinelatoQB.301.01QB.301.012024-04-15
07899798207592QuinelatoQB.302.01QB.302.012024-04-15
07899798207608QuinelatoQB.302.02QB.302.022024-04-15
07899798207615QuinelatoQB.301.02QB.301.022024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275174Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275181Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275198Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275204Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275211Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275228Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275518Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275730Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275747Intrace USAPILOTIS TECH LLCHTD2026-07-03
08806373899997BENCOXCorentec Co., LtdHTD2026-06-09
04052536162000neon3Ulrich GmbH & Co. KGHTD2026-06-08
04052536162017neon3Ulrich GmbH & Co. KGHTD2026-06-08
00810189451001Surgical DesignSurgical Design, Inc.HTD2026-06-06
G8142900SF3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142900SFFPPP3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142905SF3Garish ApparelsGARISH APPARELSHTD2026-06-06
04046964683039AESCULAPAESCULAP, INC.HTD2026-06-05
00766588283463Cohesive Wrap - 2"x 5 ydsCertified Safety Manufacturing, Inc.HTD2026-06-04
10766588283460Cohesive Wrap - 2"x 5 yds - UDI/10Certified Safety Manufacturing, Inc.HTD2026-06-04
04052536161959neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161966neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161973neon3Ulrich GmbH & Co. KGHTD2026-05-28
D9282000201SUL0SMITH SAGGITAL SPLITTER-MODW.H. Holden, Inc.HTD2026-05-27
G4250601180My MedicalMy Medical Store LLCHTD2026-05-04
G4250601350My MedicalMy Medical Store LLCHTD2026-05-04
G4250602970My MedicalMy Medical Store LLCHTD2026-05-04
G4250602980My MedicalMy Medical Store LLCHTD2026-05-04
G425310840NC0My MedicalMy Medical Store LLCHTD2026-05-04
G4254402140My MedicalMy Medical Store LLCHTD2026-05-04
G4254403120My MedicalMy Medical Store LLCHTD2026-05-04