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
00749756402545DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402552DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402569DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402576DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402590DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402620DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402682DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402712DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402729DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402736DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402743DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402538DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-06-26
05060212051721Clamp Cover Red (Small) 50mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051738Clamp Cover White (Med) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051745Clamp Cover Blue (Large) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
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