FDA.reportPublic FDA data

H&H Situation Instrument Tray Kit

Primary DI
00857048006057
Brand
H&H Situation Instrument Tray Kit
Company
H&H MEDICAL CORPORATION
Model
1
Catalog number
HHSIT01
Device description
"The H&H Situational Instrument Tray (SIT) Kit is a sterile, single use kit for performing many surgical procedures immediately. The SIT Kit provides a generic set of must-have instruments in a convenient vacuum-sealed bag ready for use. The SIT kit contains:A 5.5"" Straight Crile HemostatA 4.5"" Straight Iris ScissorsA 9.75"" Medium Magill ForcepsA 6"" Mayo-Hegar needle driver, andA protective sterile field wrap"
Published
2020-07-06
Public version status
Update
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
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857048006057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857048006057008570480060578570480060570857048006057

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
072656713
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857048006064H&H Big Cinch Abdominal Bandage1BC012020-07-10
00857048006095H-Bandage Compression Dressing, Flat Fols1HBFF012020-07-10
00857048006101Thin H Compression Bandage, Standard Fold1HBT012020-07-10
00857048006118Thin H Compression Dressing, Flat Fold1HBTF2020-07-10
00857048006125Mini Compression Bandage1HHMCB012020-07-10
00857048006392SWAT-T Elastic Tourniquet, Black1SWAT-T-BLK-EA2020-12-31
00857048006422SWAT-T Elastic Tourniquet, Orange1SWAT-T-BLK-EA2020-12-31
00857048006316TK-4 Elastic Tourniquet1TK-42020-12-31
00857048006323TK-4L Elastic Tourniquet1TK-4L2020-12-31
00857048006484H&H Combat Medic Tape1CMRT012020-12-31
00857048006361H&H Compressed Gauze1HHPG2020-12-31
00857048006521H&H Flat Compressed Gauze1HHPF2020-12-31
00857048006538H&H TACgauze Wound Wrapping Gauze1TACG022020-12-31
00857048006545H&H MiniTAC Wound Wrapping Gauze1HHMTG012020-12-31
00857048006088H-Bandage Compression Dressing - Rolled1HB012020-07-10
00857048006583H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006590H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006132Bolin Chest Seal6BCS012020-12-31
00857048006552H&H 30fr Nasopharyngeal Airway, Each1.0HHNPA-EA2020-12-31
00857048006286Bolin Chest Seal6BCS012020-12-31

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