FDA.reportPublic FDA data

Cerclage Passer

Primary DI
00854515008675
Brand
Cerclage Passer
Company
Unique Surgical
Model
Adjustable, Small
Published
2025-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00854515008675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854515008675008545150086758545150086750854515008675

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
818-813-8527info@UniqueSurgical.com

Regulatory Flags#

DUNS number
079820535
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
00850080482063Drill BitBayonet Drill Bit Ø3.2 L152026-01-30
00850080482070Drill BitBayonet Drill Bit Ø3.2 L202026-01-30
00850080482087Drill BitBayonet Drill Bit Ø3.2 L252026-01-30
00850080482094Drill BitBayonet Drill Bit Ø3.2 L302026-01-30
00850080482100Drill BitBayonet Drill Bit Ø3.2 L352026-01-30
00850080482117Drill BitBayonet Drill Bit Ø3.2 L402026-01-30
00850080482124Drill BitBayonet Drill Bit Ø3.2 L452026-01-30
00850080482131Drill BitBayonet Drill Bit Ø3.2 L502026-01-30
00850080482148Drill BitBayonet Drill Bit Ø3.2 L552026-01-30
00850080482155Drill BitBayonet Drill Bit Ø3.2 L602026-01-30
00850080482162Drill BitBayonet Drill Bit Ø3.2 L652026-01-30
00850080482179Drill BitBayonet Drill Bit Ø3.2 L702026-01-30
00850080482186Drill BitBayonet Drill Bit Ø3.2 L752026-01-30
00850080482193Drill BitBayonet Drill Bit Ø3.2 L802026-01-30
00854515008002ImpactorFemoral2023-01-06
00854515008989Medacta Glenosphere Impactor TipCannulated2025-09-16
00854515008927ScrewdriverU-Joint, 3.5mm Hex, Hudson Connector2025-08-07
00854515008934ScrewdriverSolid Shaft, 3.5mm Hex, Hudson Connector2025-08-07
00850080482025Screw ForcepsMedacta, with Cap2025-12-18
00850080482032Bone PinMedacta, Fluted2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
07613327697209PANGEAStryker GmbHLXH2026-08-27
00840606185950ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185967ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26