FDA.reportPublic FDA data

Viscera Retainer, Fish

Primary DI
61324400003500
Brand
Viscera Retainer, Fish
Company
ADEPT MED INTERNATIONAL INC
Model
3206
Device description
Large Viscera Retainer
Published
2023-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCZRetainer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCZRetainer, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K802806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K802806000VISECERA RETAINERAdept-Med Intl., Inc.1981-01-23GCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613244000035PrimaryGS10
61324400003500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613244000035006132440000356132440000350613244000035
6132440000350061324400003500

GMDN Terms#

Term, Definition table
TermDefinition
Viscera retention paddleA sterile, hand-held, flat device designed to be temporarily placed within a body cavity to retain and protect organs (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is in the form of a thin, flexible, synthetic polymer paddle that may have an attached cord that remains outside the body to assist in device removal prior to external wound closure. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5306211220sales@adeptmed.com

Regulatory Flags#

DUNS number
044962397
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613244000011Viscera Retainer, Fish32002023-02-16
00613244000028Viscera Retainer, Fish32022023-02-16
00613244000042Viscera Retainer, Fish32072023-02-16
00613244000004Viscera Retainer, Fish32042023-02-16
00613244000035Viscera Retainer, Fish32062023-02-16
00613244000066Viscera Retainer, Fish32122023-02-16
61324400001100Viscera Retainer, Fish32002023-02-16
61324400002800Viscera Retainer, Fish32022023-02-16
61324400004200Viscera Retainer, Fish32072023-02-16
00613244000059Breast Implant Protector32082023-02-16
61324400006600Viscera Retainer, Fish32122023-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511123086Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123093Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123109Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123116Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123123Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123130Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123147Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00613244000011Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000028Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000035Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000042Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000066Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000004Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400001100Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400002800Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400004200Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000059Breast Implant ProtectorADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400006600Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
90841823104260Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104277Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104284Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104291Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104307Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104314Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104321Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104338Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104345Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
00816101010363Cross Element Guide RetainerTOBY ORTHOPAEDICSGCZ2020-08-28
00816101010370Cross Element Guide SleeveTOBY ORTHOPAEDICSGCZ2020-08-28
00816101010394Post Drill Guide Sleeve, 28mmTOBY ORTHOPAEDICSGCZ2020-08-28