FDA.reportPublic FDA data

Dilator-Medium

Primary DI
00857915007675
Brand
Dilator-Medium
Company
A.M. SURGICAL, INC.
Model
9600-08
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
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
00857915007675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857915007675008579150076758579150076750857915007675

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, reusableA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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
00857915007767IM Nail Awl8900-202026-06-10
00857915007774Measuring Device8900-512026-06-10
00857915007804STRATOS Endoscopic Release System (GEN 2) Case of 55500-B2026-06-10
00857915007811Table Pad95012026-06-10
10857915007818Table Pads (5-pack)9501-B2026-06-10
20857915007815STRATOS Endo Release Kit (GEN 2) Case of 55500-K2026-06-10
00857915007705STRATOS (Gen2)5500-22026-06-05
00857915007033RetraBE Single - Gen 2 Depricated5500-SRB2026-06-04
00857915007743Hand Table95002026-06-04
00857915007750Endo ECTR Tray96002026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)5500-UB2026-06-04
00857915007798Retra Uni Gen 1 Single5500-U2026-06-04
10857915007030RETRA Single - GEN 2 Depricated5500-RB2026-06-04
00857915007026Scope Adapter1200-012026-06-01
00857915007712Obturator9600-012026-06-01
00857915007729Cannula9600-022026-06-01
00857915007736Rasp9600-032026-06-01
00857915007699Locking Attachment9600-042026-05-20
00857915007132Stratos55002019-07-17
10857915007047RETRA5500-RN/A2026-05-20

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Primary DI, Brand, Company table
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10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16