FDA.reportPublic FDA data

ATOE-Stainless Steel

Primary DI
00810072351142
Brand
ATOE-Stainless Steel
Company
Cole Instruments Inc
Model
ATOE-Stainless Steel
Catalog number
380.000
Device description
Aide To Extraction (ATOE), made of stainless steel. Used in extracting follicles after being punches.
Published
2022-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRQHemostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810072351142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810072351142008100723511428100723511420810072351142

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078573265
Device count
1
Premarket exempt
true
Sterilization required before use
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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