FDA.reportPublic FDA data

HypoFoam

Primary DI
00860013471606
Brand
HypoFoam
Company
TyTek Medical Inc.
Model
1000
Device description
Single-use foam block for use with HypoHolder system
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013471606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013471606008600134716068600134716060860013471606

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument interim-placement holder, single-useA device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
078589992
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010987902Surgical HypoHolder10032025-06-27
00860010987940Clinical HypoHolder10042025-06-27
00860010987926HypoPan10092025-06-17
00855204008006TPAKTM-303TM-3032019-10-03
00855204008013TVACTM-909TM-9092019-10-03
00855204008020Ptensys Bleeding Control StationTM-400TM-4002019-10-03
00855204008037Ptensys Bleeding Control KitsTM-401TM-4012019-10-03
00855204008051TPAKTM-310TM-3102019-10-03
00855204008068TYTEK TRAUMA BANDAGETM-204TM-2042019-10-03
00855204008075TYTEK TRAUMA BANDAGETM-206TM-2062019-10-03
00855204008082TYTEK TRAUMA BANDAGETM-212TM-2122019-10-03
00855204008099EZ GAUZETM-215TM-2152019-10-03
00855204008167PneumoDartTM-317TM-3172019-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160500040Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDC2025-10-28
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10653160385769MEDLINEMEDLINE INDUSTRIES, INC.KDC2025-01-29
10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
10653160383123MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383130MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383147MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160382119MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-04
10653160381501MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-18
10653160381228MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160381334MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160379874CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-09-11
10653160379232MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-08-28
10653160375128MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160375340MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160374183CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-05-02
10653160369592CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-18
10653160369462CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-11
10653160369431CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160369448CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160365815CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-09-05
10080196415472MedlineMEDLINE INDUSTRIES, INC.KDC2023-06-22
10705031470507MERSILENEETHICON, LLCKDC2023-05-30
10653160360766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-05-29
10653160359197CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-03-17
10810102270921Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270938Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270945Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270952Dermapac, Inc.Dermapac Inc.KDC2022-09-12