FDA.reportPublic FDA data

Locking Attachment

Primary DI
00857915007699
Brand
Locking Attachment
Company
A.M. SURGICAL, INC.
Model
9600-04
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857915007699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857915007699008579150076998579150076990857915007699

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
160020087
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857915007047RETRA5500-RN/A2026-05-20
00857915007040RETRA5500-SR2026-05-20
00857915007651Elevator9600-062026-05-20
00857915007668Dilator-Small9600-072026-05-20
00857915007675Dilator-Medium9600-082026-05-20
00857915007682Dilator-Large9600-092026-05-20
00857915007286Secure IM Nail8960-652019-11-14
00857915007293Secure IM Nail8960-702019-11-14
00857915007309Secure IM Nail8912-302019-11-14
00857915007316Secure IM Nail8912-352019-11-14
00857915007323Secure IM Nail8912-402019-11-14
00857915007330Secure IM Nail8912-452019-11-14
00857915007347Secure IM Nail8912-502019-11-14
00857915007354Secure IM Nail8912-552019-11-14
00857915007361Secure IM Nail8912-602019-11-14
00857915007378Secure IM Nail8912-652019-11-14
00857915007385Secure IM Nail8912-702019-11-14
00857915007057Secure IM Nail8960-402018-07-16
00857915007064Secure IM Nail8960-452018-07-16
00857915007071Secure IM Nail8960-502018-07-16

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Primary DI, Brand, Company table
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10080196385386MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385478MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
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