FDA.report

Caplugs/Evergreen

Primary DI
00810044205091
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
500
Catalog number
333-5005-U10
Device description
INNOC 5UL LOOP & ARROWHD
Published
2021-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810044204810PrimaryGS10
00810044205091Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044204810008100442048108100442048100810044204810
00810044205091008100442050918100442050910810044205091

GMDN Terms

TermDefinition
Inoculating tool IVD, manualA hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender handle with an attached loop or swab on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(716)876-9855christine.koch@caplugs.com

Regulatory Flags

DUNS number
098203461
Device count
500
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810044208375Caplugs/Evergreen127-1758-B20127-1758-B202026-02-06
00810044208382Caplugs/Evergreen127-1758-Y20127-1758-Y202026-02-06
00810044206944Caplugs/Evergreen208-3366-050208-3366-0502024-05-31
00810044206951Caplugs/Evergreen208-3367-050208-3367-0502024-05-31
00810044206968Caplugs/Evergreen208-3368-050208-3368-0502024-05-31
00810044206975Caplugs/Evergreen208-3383-03K208-3383-03K2024-05-31
00810044206982Caplugs/Evergreen208-3383-060208-3383-0602024-05-31
00810044206999Caplugs/Evergreen208-3384-060208-3384-0602024-05-31
00810044207002Caplugs/Evergreen208-3385-060208-3385-0602024-05-31
00810044207019Caplugs/Evergreen208-3385-06R208-3385-06R2024-05-31
00810044207026Caplugs/Evergreen208-3385-06S208-3385-06S2024-05-31
00810044207033Caplugs/Evergreen208-3376-050208-3376-0502024-05-31
00810044207040Caplugs/Evergreen208-3377-050208-3377-0502024-05-31
00810044207057Caplugs/Evergreen208-3378-050208-3378-0502024-05-31
00810044207064Caplugs/Evergreen208-3392-060208-3392-0602024-05-31
00810044207071Caplugs/Evergreen208-3393-060208-3393-0602024-05-31
00810044207088Caplugs/Evergreen208-3394-060208-3394-0602024-05-31
00810044207095Caplugs/Evergreen208-1289-03S208-1289-03S2024-05-31
00810044207101Caplugs/Evergreen208-3049-030208-3049-0302024-05-31
00810044207118Caplugs/Evergreen208-3049-03S208-3049-03S2024-05-31

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