FDA.reportPublic FDA data

ACL DISPOSABLE INSTRUMENTATION

Primary DI
00880304567085
Brand
ACL DISPOSABLE INSTRUMENTATION
Company
Biomet Orthopedics, LLC
Model
110004136
Catalog number
110004136
Published
2017-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304567085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304567085008803045670858803045670850880304567085

GMDN Terms#

Term, Definition table
TermDefinition
Ligament reconstruction instrument set, reusableA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

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Primary DI, Brand, Company table
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00850074437116OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
50885380211193Aero-MedAERO-MED, LLCKDD2026-02-13
10653160392248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2026-02-11
07901125600584Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600591Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600607Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600614Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
50749756397808DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-01-22
10653160391302MedlineMEDLINE INDUSTRIES, INC.KDD2026-01-15
50885380206656Aero-MedAERO-MED, LLCKDD2026-01-15
00887868572524ToggleLoc™ WasherLoc™Biomet Orthopedics, LLCKDD2026-01-14
00850074437123OftalOnePackOFTAL-ONE INC.KDD2026-01-05
10653160390671Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2025-12-04
08800071700517TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
40198459450649MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459453510MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459454647MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459455231MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459456238MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459697MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459765MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459888MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459460044MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459471767MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459473846MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459474669MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459476106MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18