FDA.reportPublic FDA data

Citrelock ACL 7mm Femoral Drill Guide, Straight Tip

Primary DI
00810027271617
Brand
Citrelock ACL 7mm Femoral Drill Guide, Straight Tip
Company
Acuitive Technologies, Inc.
Model
40-103-0071
Catalog number
40-103-0071
Published
2024-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810027271617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810027271617008100272716178100272716170810027271617

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
201-661-2680mpoggie@acuitivetech.com

Regulatory Flags#

DUNS number
074645634
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100272722943cc Citregraft Cylinder36-106-000436-106-00042025-10-01
008100272723006cc Citregraft Cylinder36-106-000536-106-00052025-10-01
0081002727231712.5cc Citregraft Cylinder36-106-000636-106-00062025-10-01
00810027271594Citrelock ACL Tibial Drill Guide, Flat Hook40-103-001640-103-00162024-12-03
00810027271600Citrelock ACL 6mm Femoral Drill Guide, Straight Tip40-103-006140-103-00612024-12-03
00810027271624Citrelock ACL 1.5mm K-Wire40-103-001540-103-00152024-12-03
00810027270436Citrefix 2.9mm Inserter40-100-402940-100-40292023-06-24
00810027270443Citrefix 3.5mm Inserter40-100-403540-100-40352023-06-24
00810027270450Citrefix 4.5mm Inserter40-100-404540-100-40452023-06-24
00810027270467Citrefix 5.5mm Inserter40-100-405540--100-40552023-06-24
00810027270894Citrefix 2.9mm Inserter Center Shaft40-100-102940-100-10292023-06-24
00810027270900Citrefix 3.5mm Inserter Center Shaft40-100-103540-100-10352023-06-24
00810027270917Citrefix 4.5mm Inserter Center Shaft40-100-104540-100-10452023-06-24
00810027270924Citrefix 5.5mm Inserter Center Shaft40-100-105540-100-10552023-06-24
00810027271051Citrefix 2.9mm Inserter Plunger40-100-202940-100-20292023-06-24
00810027271068Citrefix 3.5mm Inserter Plunger40-100-203540-100-20352023-06-24
00810027271075Citrefix 4.5mm Inserter Plunger40-100-204540-100-20452023-06-24
00810027271082Citrefix 5.5mm Inserter Plunger40-100-205540-100-20552023-06-24
00810027271099Citrefix Center Shaft Retaining Clamp40-100-001040-100-00102023-06-24
00810027271105Citrelock ACL Inserter40-103-000340-103-00032023-06-23

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00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
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