FDA.reportPublic FDA data

Ace Medical Company

Primary DI
00840217910408
Brand
Ace Medical Company
Company
EBNER MEDICAL, LLC
Model
AM-859-06
Device description
MICRO N H STREAMLINE DESIGN L:230MM ROUND HANDLED:8MM W/O RATCHET STR. JAWS l:1,0MM WC
Published
2026-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217910408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217910408008402179104088402179104080840217910408

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-822-0314info@acemedicalco.com

Regulatory Flags#

DUNS number
106135367
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840217910170Ace Medical CompanyAA4021010AA40210102026-08-13
00840217910187Ace Medical CompanyAA4021015AA40210152026-08-13
00840217910194Ace Medical CompanyAA4021023AA40210232026-08-13
00840217910200Ace Medical CompanyAA4021223AA40212232026-08-13
00840217910217Ace Medical CompanyAA4021215AA40212152026-08-13
00840217910224Ace Medical CompanyAA4021410AA40214102026-08-13
00840217910231Ace Medical CompanyAA4021415AA40214152026-08-13
00840217910248Ace Medical CompanyAA40214232026-08-13
00840217910255Ace Medical CompanyAA4021605AA40216052026-08-13
00840217910262Ace Medical CompanyAA4021608AA40216082026-08-13
00840217910279Ace Medical CompanyECA-A008ECA-A0082026-08-13
00840217910286Wiggins Medical90-070-25FB90-070-25FB2026-08-13
00840217910293Ace Medical CompanyER806.000PAER806.000PA2026-08-13
00840217910309Ace Medical CompanyER806.000VAER806.000VA2026-08-13
00840217910316Ace Medical CompanyER300.010ERER300.010ER2026-08-13
00840217910323Ace Medical CompanyER305.200ER1ER305.200ER12026-08-13
00840217910330Ace Medical CompanyER305.150EER305.150E2026-08-13
00840217910347Ace Medical CompanyER300.020BAER300.020BA2026-08-13
00840217910354Ace Medical CompanyER390.070ER390.0702026-08-13
00840217910361Wiggins Medical90-070-18FB2026-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435097MillenniumAvalign Technologies, Inc.HXK2026-10-15
04058749027969NAFehling Instruments GmbH & Co. KGHXK2026-10-12
00190776432782MillenniumAvalign Technologies, Inc.HXK2026-09-29
00724995268916Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268923Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268930Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268947Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268954Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268961Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268978Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
04054462904747evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904754evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904761evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904778evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904785evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904792evonosevonos GmbH & Co. KGHXK2026-08-21
00850088713428PRINCETONPrinceton Medical Group, Inc.HXK2026-08-14
00840217910392Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910415Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910422Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910439Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910446Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910453Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910460Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910477Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910484Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
04058749047196NAFehling Instruments GmbH & Co. KGHXK2026-07-17
04058749117387NAFehling Instruments GmbH & Co. KGHXK2026-07-17
00850083275235Intrace USAPILOTIS TECH LLCHXK2026-07-03
00850083275594Intrace USAPILOTIS TECH LLCHXK2026-07-03