FDA.reportPublic FDA data

AHSAD

Primary DI
00810072350879
Brand
AHSAD
Company
Cole Instruments Inc
Model
AHSAD
Catalog number
401.000
Device description
Assist to Hairline Surface Area Determination. Can assist in surface for donor or receipient area.
Published
2021-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810072350879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810072350879008100723508798100723508790810072350879

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078573265
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100723505030.80 mm window punch, 5 packIHTI-0.80-2S-094-WP punch109.0802021-02-04
008100723505100.80 mm window punch, 10 packIHTI-0.80-2S-094-WP punch109.0802021-02-04
00810072351197Graft Slivering BoardGraft Slivering Board621.0002022-12-08
00810072351005mini Powered Cole Isolation DevicemPCID910.0002021-02-04
00810072351159Graft Storage PlateGraft Storage Plate360.1002022-12-08
008100723500460.80 mm regular punch, 5 packCI-0.80-3C-094 punch102.0802021-02-04
008100723500530.80 mm regular punch, 10 packCI-0.80-3C-094 punch102.0802021-02-04
008100723500600.85 mm regular punch, 5 packCI-0.85-3C-094 punch102.0852021-02-04
008100723500770.85 mm regular punch, 10 packCI-0.85-3C-094 punch102.0852021-02-04
008100723500840.90 mm regular punch, 5 packCI-0.90-3C-094 punch102.0902021-02-04
008100723500910.90 mm regular punch, 10 packCI-0.90-3C-094 punch102.0902021-02-04
008100723501070.95 mm regular punch, 5 packCI-0.95-3C-094 punch102.0952021-02-04
008100723501140.95 mm regular punch, 10 packCI-0.95-3C-094 punch102.0952021-02-04
008100723501211.00 mm regular punch, 5 packCI-1.00-3C-094 punch102.1002021-02-04
008100723501381.00 mm regular punch, 10 packCI-1.00-3C-094 punch102.1002021-02-04
008100723501451.05 mm regular punch, 5 packCI-1.05-3C-094 punch102.1052021-02-04
008100723501521.05 mm regular punch, 10 packCI-1.05-3C-094 punch102.1052021-02-04
008100723501691.10 mm regular punch, 5 packCI-1.10-3C-094 punch102.1102021-02-04
008100723501761.10 mm regular punch, 10 packCI-1.10-3C-094 punch102.1102021-02-04
008100723502200.90 mm non-coated titanium punch, 5 packCI-0.90-2T1-094 punch103.0902021-02-04

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Primary DI, Brand, Company table
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