FDA.reportPublic FDA data

Fixate™ Suturing Device

Primary DI
M365FB101010
Brand
Fixate™ Suturing Device
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
SC-4317-01
Catalog number
SC-4317-01
Device description
Fixate™ Suturing Device
Published
2014-09-24
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

Product Codes#

Code, Name table
CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M365FB101010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
824951958
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506070564NANM-7174M365NM717402026-06-08
00191506070595NADB-7174M365DB717402026-06-08
08714729789550Linear™ 3-4SC-2352-502015-12-15
08714729789574Linear™ 3-6SC-2366-502015-12-15
08714729789659Linear™ 3-6SC-2366-302015-12-14
08714729896098NADB-42522017-12-15
08714729896104NADB-42542017-12-15
08714729896111NADB-4100A2017-12-15
08714729931751NADB-43202017-12-12
08714729965848Vercise™DB-64125-US2017-12-12
08714729121466Precision™SC-43002015-11-09
08714729121473Precision™SC-43052015-11-09
08714729121480Precision™SC-43102015-11-09
08714729767572Precision ™SC-42302015-11-09
08714729767626Precision™SC-43062015-11-09
08714729767756Precision™SC-43012015-11-09
08714729767763Precision™SC-43112015-11-09
08714729888734Precision™SC-9218-152015-12-14
08714729888758Precision™SC-9218-552015-12-14
08714729893271Precision™SC-9208-152015-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081253703743125cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
0081253703744840cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZB2026-02-26
00812537037691Lead Kit (4 Contact, 25cm, Tined)NALU MEDICAL, INC.GZB2026-02-26
00812537037141TD2 Limb CuffNALU MEDICAL, INC.GZB2026-02-25
00812537037158TD2 Thigh WrapNALU MEDICAL, INC.GZB2026-02-25
00812537037165TD2 Relief Belt, LargeNALU MEDICAL, INC.GZB2026-02-25
00812537037172TD2 Relief Belt, SmallNALU MEDICAL, INC.GZB2026-02-25
00812537037257Charger KitNALU MEDICAL, INC.GZB2026-02-25
00812537036984Base Station ChargerNALU MEDICAL, INC.GZB2026-02-24
00812537037127TD2 Patient KitNALU MEDICAL, INC.GZB2026-02-20
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537035802Therapy Disc, Reduced WarrantyNALU MEDICAL, INC.GZB2026-01-19
00812537037134TD2 Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537037660Nalu Medical, Inc.NALU MEDICAL, INC.GZB2025-12-08
00888867525924Arthrex®ARTHREX, INC.GAT2025-10-20
00888867525931Arthrex®ARTHREX, INC.GAT2025-10-20
00812537037189Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037202Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037219Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037332Nalu MedicalNALU MEDICAL, INC.GZB2024-05-01
00812537037349Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037356Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537036021Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-01-02
00812537036854Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537036861Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537036878Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537036885Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537034317Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-09-30