FDA.reportPublic FDA data

Self-Filling Device

Primary DI
00810072350909
Brand
Self-Filling Device
Company
Cole Instruments Inc
Model
Self-Filling Device
Catalog number
500.002
Device description
Self-Filling Device
Published
2021-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810072350909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810072350909008100723509098100723509090810072350909

GMDN Terms#

Term, Definition table
TermDefinition
Syringe-loaded injector, manual, professionalA hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) or subcutaneously. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. This is a reusable device.

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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