FDA.reportPublic FDA data

Pecaplasty Wires First Single Use kit(1052)

Primary DI
00850078396426
Brand
Pecaplasty Wires First Single Use kit(1052)
Company
Eca Medical Instruments
Model
1052
Catalog number
1052
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00850078396426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078396426008500783964268500783964260850078396426

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
084330422
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078396297TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lb228-TXRX-010228-TXRX-0102026-10-20
00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)228-TXRX-009228-TXRX-0092026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)228-TXRX-008228-TXRX-0082026-10-20
00850078396389TruTORQ Offset T-Handle Sterile, Single Use803-005803-0052026-10-20
00850078396440SYNQ Single-Use Instrument System(1066)106610662026-10-19
00850078396433PecaPusher(1061)106110612026-09-29
00850078396457Ti-TEQ Implant Extractor(1056)105610562026-09-29
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)105410542026-08-18
00850078396334OSSIO Drill Bit, 5.9mm Cannulated (1058)105810582026-08-14
00850078396341OSSIO 6.0mm Cannulated Drill Bit( 1059)105910592026-08-14
00850078396358OSSIO 6.1mm Cannulated Drill Bit(1060)106010602026-08-14
00857676008546LINQ Surgery Ready Instrument SystemLQG39652024-02-16
008500783961982.2 TITAN Nail Instrument KitF15-A-2784S1047-0012026-06-23
008500783962043.0 TITAN Nail Instrument KitF15-A-2884S1047-0022026-06-23
008500783962284.0 TITAN Nail Instrument KitF15-A-8004.30S1047-0032026-06-23
008500783962352.2-4.0 TITAN Nail SizerF15-A-2084S10482026-06-23
008500783962422.2 TITAN Nail Accessory KitF15-A-2785S1049-0012026-06-23
008500783962593.0 TITAN Nail Accessory KitF15-A-2885S1049-0022026-06-23
008500783962734.0 TITAN Nail Accessory KitF15-A-8004.31S1049-0032026-06-23
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)228-TXRX-006228-TXRX-0062026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21