FDA.reportPublic FDA data

STERILE .010 NITINOL WIRE

Primary DI
00880304547292
Brand
STERILE .010 NITINOL WIRE
Company
Biomet Orthopedics, LLC
Model
904020
Catalog number
904020
Published
2020-05-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXIPASSER, WIRE, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304547292PrimaryGS10
70880304547291Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304547292008803045472928803045472920880304547292
7088030454729170880304547291

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting pliersA heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04047844130964DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130971DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
04047844130988DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
10810128464137WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-07-22
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15
00841731138095TITANEX VILEX LLCHXI2026-05-15
00841731142870TITANEX VILEX LLCHXI2026-05-15
00841731142887TITANEX VILEX LLCHXI2026-05-15
00841731146717TITANEXVILEX LLCHXI2026-05-15
00841731146724TITANEXVILEX LLCHXI2026-05-15
00841731146731TITANEXVILEX LLCHXI2026-05-15
00841731147141TITANEX VILEX LLCHXI2026-05-15
00889795152671Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152688Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152695Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
B8034803860ORTHOMEDORTHO-MED, INC.HXI2026-04-16
B8034803880ORTHOMEDORTHO-MED, INC.HXI2026-04-16
00840311246830Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXI2026-03-18
10810128462645Nitinol Loop Passer MEDACTAT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-02-09
00841731134769Hintermann Series VILEX LLCHXI2026-01-16
06974940306369endophixSuzhou Endophix Co., Ltd.HXI2025-12-12
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06974940306185endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306192endophixSuzhou Endophix Co., Ltd.HXI2025-12-05