FDA.reportPublic FDA data

Carerite®

Primary DI
07290016678161
Brand
Carerite®
Company
STEPAC L.A. LTD.
Model
1
Device description
"6"" Nylon Sterilization Pouch"
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870147000CARERITE & COST RITE NYLON STERILIZATION FILMCost Rite Health Products, Inc.1987-04-23FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016678168PackageGS112In Commercial Distribution
07290016678161PrimaryGS10
37290016678162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001667816817290016678168
07290016678161072900166781617290016678161
3729001667816237290016678162

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600402291
Device count
100
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00729001667806Carerite®12017-08-18
07290016678062Carerite®12017-09-18
07290016678017Carerite®12017-08-18
07290016678024Carerite®12017-08-18
07290016678031Carerite®12017-08-18
07290016678048Carerite®12017-08-18
07290016678055Carerite®12017-08-18
17290016678069Carerite®12017-09-18
07290016678079Carerite®12017-08-18
07290016678086Carerite®12017-08-18
07290016678093Carerite®12017-08-18
07290016678109Carerite®12017-08-18
07290016678116Carerite®12017-08-18
07290016678123Carerite®12017-08-18
07290016678130Carerite®12017-08-18
07290016678147Carerite®12017-08-18
07290016678154Carerite®12017-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
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10686864061912MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
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