FDA.reportPublic FDA data

ACE

Primary DI
00614950019830
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0100308
Catalog number
0100308
Device description
"HOOK SKIN FREER DOUBLE SHARP 2MM WIDE 6"" 15CM"
Published
2019-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950019830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950019830006149500198306149500198300614950019830

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, single-useA sterile, hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct) to allow surgical intervention on those tissues. It is not primarily designed for pulling aside tissues for surgical access purposes (i.e., not a retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950025510ACE003293700329372019-10-24
00614950025558ACE080000208000022019-10-24
00614950025565ACE080000308000032019-10-24
00614950025572ACE080001108000112019-10-24
00614950013425ACE003105900310592019-10-16
00614950031207ACE484200248420022023-12-05
00614950031214ACE484200348420032023-12-05
00614950030149ACE20982511209825112023-12-05
00614950030927ACE45450201454502012023-12-05
00614950012831ACE90440018S90440018S2019-10-13
00614950012848ACE90440018ST90440018ST2019-10-13
00614950026272ACE90250018902500182019-10-13
00614950026289ACE90250023902500232019-10-13
00614950026296ACE90440018904400182019-10-13
00614950026302ACE90440023904400232019-10-13
00614950026319ACE90440023S90440023S2019-10-13
00614950026326ACE90440023ST90440023ST2019-10-13
00614950026333ACE90500018905000182019-10-13
00614950026340ACE90500018S90500018S2019-10-13
00614950026357ACE90500023905000232019-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183531232BR Surgical, LLCBR Surgical, LLCGDG2026-07-21
B382SD907505200Surgical DirectSurgical Direct, Inc.GDG2026-07-17
B382SD907505210Surgical DirectSurgical Direct, Inc.GDG2026-07-17
00190776395674MillenniumAvalign Technologies, Inc.GDG2026-07-14
00810158216136PRINCETONPrinceton Medical Group, Inc.GDG2026-06-23
B7685252430Buxton BioMedicalBuxton Biomedical IncGDG2026-06-05
G383S1061WM3245624S7SURJEXSURJEXGDG2026-05-31
00810055258734Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258741Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258758Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258765Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258772Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258789Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258796Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258802Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258819Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258826Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258833Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258840Surgical DesignSurgical Design, Inc.GDG2026-05-29
09348811019622INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
09348811019639INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
10381780503194Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503200Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503729Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503736Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780449195Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-12-19
10381780495833Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-10-24
10381780498681Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498698Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498704Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18