FDA.reportPublic FDA data

NA

Primary DI
00810045539058
Brand
NA
Company
Integrity Implants Inc.
Model
ASY-00463
Catalog number
ASY-00463
Device description
Slap Hammer
Published
2022-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00810045539058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045539058008100455390588100455390580810045539058

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation hammering attachmentA surgical instrument designed to be attached to another surgical implantation instrument or directly to an orthopaedic implant to provide a surface on which an operating surgeon can make strikes, with a surgical hammer or mallet, to insert an orthopaedic implant (e.g., an intramedullary nail). It is typically made of high-grade stainless steel and typically in the form of a cylindrical shaft with a threaded portion at the distal end (i.e., threaded into the implant or connected to the implantation instrument) and a broader, robust striking head (surface) at the proximal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8002019300customerservice@integrityimplants.com

Regulatory Flags#

DUNS number
080300717
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00840200410656NACMP-03002CMP-030022025-07-17
00810045530307FlareHawkFHPACS0025PTSFHPACS0025PTS2022-12-08
00810045530314FlareHawkFHPACT0025PTSFHPACT0025PTS2022-12-08
00810045530321FlareHawkFHPACT0925PTSFHPACT0925PTS2022-12-08
00810045530338FlareHawkFHTACS0029PTSFHTACS0029PTS2022-12-08
00810045530345FlareHawkFHTACT0029PTSFHTACT0029PTS2022-12-08
00810045530352FlareHawkFHTACT0929PTSFHTACT0929PTS2022-12-08
00810045530567FlareHawkFHTPCS0026PTSFHTPCS0026PTS2022-12-08
00810045530574FlareHawkFHTPCT0026PTSFHTPCT0026PTS2022-12-08
00810045530581FlareHawkFHTPCS0030PTSFHTPCS0030PTS2022-12-08
00810045530598FlareHawkFHTPCT0030PTSFHTPCT0030PTS2022-12-08
00810045530680FlareHawkFHTPS200267SFHTPS200267S2022-12-12
00810045530697FlareHawkFHTPS300267SFHTPS300267S2022-12-12
00810045530703FlareHawkFHTPS400267SFHTPS400267S2022-12-12
00810045530710FlareHawkFHTPS500267SFHTPS500267S2022-12-12
00810045530727FlareHawkFHTPS106267SFHTPS106267S2022-12-12
00810045530734FlareHawkFHTPS206267SFHTPS206267S2022-12-12
00810045530741FlareHawkFHTPS306267SFHTPS306267S2022-12-12
00810045530758FlareHawkFHTPS200307SFHTPS200307S2022-12-12
00810045530765FlareHawkFHTPS300307SFHTPS300307S2022-12-12

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Primary DI, Brand, Company table
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00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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